- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00934089
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
April 6, 2021 updated by: Pfizer
A Phase 2, Single-masked, Randomized, Crossover Study Of The 24-hour Intraocular Pressure Lowering And Systemic Exposure of Pf-04217329 Alone And In Combination With Latanoprost
This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients.
Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- West Coast Clinical Trials, Llc
-
Garden Grove, California, United States, 92844
- Glory Medical Group
-
Gardena, California, United States, 90247
- East-West Eye Institute
-
Long Beach, California, United States, 90806
- Ophthalmology Corporation
-
Los Angeles, California, United States, 90013
- East-West Eye Institute
-
Los Angeles, California, United States, 90057
- Los Angeles Eye Medical Group
-
Newport Beach, California, United States, 92663
- Eye Research Foundation
-
Pasadena, California, United States, 91105
- Southern California Glaucoma Consultants
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
- Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
- Visual acuity correctable to 20/100 or better in each eye.
Exclusion Criteria:
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
- Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
- Advanced glaucoma or a history of severe central visual field loss in either eye.
- History of ocular surgery or trauma in either eye within 6 months of the screening visit.
- History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PF-04217329 + placebo
Active study drug + latanoprost vehicle
|
Topical ocular solution, once-daily for 14 days
Topical ocular solution, once-daily for 14 days
|
EXPERIMENTAL: PF-04217329 + latanoprost
Active study drug + latanoprost
|
Topical ocular solution, once-daily for 14 days
Topical ocular solution, once-daily for 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour)
Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 14.
|
8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours)
Time Frame: 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury, mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 10 AM on Day -8 as baseline for 10 AM value on Day 14.
|
10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours)
Time Frame: 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 12 PM on Day -8 as baseline for 12 PM value on Day 14.
|
12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours)
Time Frame: 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 2 PM on Day -8 as baseline for 2 PM value on Day 14.
|
2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours)
Time Frame: 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 4 PM on Day -8 as baseline for 4 PM value on Day 14.
|
4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours)
Time Frame: 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 6 PM on Day -8 as baseline for 6 PM value on Day 14.
|
6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours)
Time Frame: 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both the eyes, and eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 PM on Day -8 as baseline for 8 PM value on Day 14.
|
8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours)
Time Frame: 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 10 PM on Day -8 as baseline for 10 PM value on Day 14.
|
10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours)
Time Frame: 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 12 AM on Day -7 as baseline for 12 AM value on Day 15.
|
12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours)
Time Frame: 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 4 AM on Day -7 as baseline for 4 AM value on Day 15.
|
4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours)
Time Frame: 6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point.
If difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 6 AM on Day -7 as baseline for 6 AM value on Day 15.
|
6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours)
Time Frame: 8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 AM on Day -7 as baseline for 8 AM value on Day 15.
|
8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours)
Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 16.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 16.
|
8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours)
Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 17. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 17.
|
8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)
|
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours)
Time Frame: 8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)
|
IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 21.
IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both measurements were equal, right eye was selected as study eye.
IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 2 readings was recorded as the IOP at that time point.
If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point.
Mean IOP was reported as the average of individual participants' mean or median IOP values.
Change from baseline in IOP = baseline IOP - post-baseline IOP.
Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 21.
|
8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)
|
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14
Time Frame: 5 minutes post-dose on Day 14
|
5 minutes post-dose on Day 14
|
|
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14
Time Frame: 0.25 hours post-dose on Day 14
|
0.25 hours post-dose on Day 14
|
|
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14
Time Frame: 0.5 hours post-dose on Day 14
|
0.5 hours post-dose on Day 14
|
|
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14
Time Frame: 0.75 hours post-dose on Day 14
|
0.75 hours post-dose on Day 14
|
|
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14
Time Frame: 1 hour post-dose on Day 14
|
1 hour post-dose on Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic Ocular Perfusion Pressure (DOPP)
Time Frame: 8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM on Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day 15
|
DOPP = diastolic blood pressure minus IOP of the study eye.
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit and Day 15.
IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both the measurements were equal, right eye was selected as the study eye.
|
8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM on Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day 15
|
Change From Baseline in Diastolic Ocular Perfusion Pressure (DOPP) at Day 14 (8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM) and Day 15 (12 AM, 2 AM, 4 AM, 6 AM and 8 AM)
Time Frame: 8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, and 10 PM on Day -8 (Baseline), Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day -7 (Baseline), Day 15
|
DOPP=diastolic blood pressure minus IOP of the study eye.
IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15.
IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment.
If both the measurements were equal, right eye was selected as the study eye.
Change at various post-dose time points on Day 14 and Day 15 was calculated from the values at same time points on Day -8 and Day -7 respectively (for example, value at 8 AM on Day -8 was used as baseline value for 8 AM value on Day 14 and value at 8 AM on Day -7 was used as baseline value for 8 AM value on Day 15).
|
8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, and 10 PM on Day -8 (Baseline), Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day -7 (Baseline), Day 15
|
Number of Participants With Ocular and Systemic Adverse Events (AEs)
Time Frame: Baseline up to 28 days after last dose of study medication (up to 58 Days)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of participants with ocular (AE related to eye) and systemic (all AEs including eye) AEs were reported.
|
Baseline up to 28 days after last dose of study medication (up to 58 Days)
|
Percentage of Participants With Photophobia and Iritis
Time Frame: Baseline up to 28 days after last dose of study medication (up to 58 Days)
|
Percentage of participants with treatment emergent photophobia (abnormal sensitivity or intolerance of eye towards light) and iritis (inflammation of the iris of eye) were reported.
Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
|
Baseline up to 28 days after last dose of study medication (up to 58 Days)
|
Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35
Time Frame: 8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35
|
Corneal thickness was measured using an ultrasonic pachymeter.
Corneal thickness in both study eye and fellow eye were reported.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
|
8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35
|
Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35
Time Frame: 8 AM on Day 1 (Baseline), Day 13, 35
|
Endothelial cell count was defined as the number of cells per millimeter square (cells/mm^2) of endothelium and was calculated using confocal microscopy for both study eye and fellow eye.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
|
8 AM on Day 1 (Baseline), Day 13, 35
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Conjunctival Hyperemia Score
Time Frame: Day -8 (Baseline), Day 1 to 35
|
Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe).
Higher score indicated severe condition.
Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1).
Highest conjunctival hyperemia score observed at Day -8 (baseline) and through Day 1 to 35 were reported.
Maximum conjunctival hyperemia score for both study eye and fellow eye was reported.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
|
Day -8 (Baseline), Day 1 to 35
|
Change From Baseline in Maximum Conjunctival Hyperemia Score Observed
Time Frame: Day -8 (Baseline), Day 1 to 35
|
Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe).
Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1).
Change between highest conjunctival hyperemia score observed through Day 1 to 35 and highest conjunctival hyperemia score at baseline (Day -8) was reported.
Maximum conjunctival hyperemia score for both study eye and fellow eye was reported.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
|
Day -8 (Baseline), Day 1 to 35
|
Total Corneal Staining Score
Time Frame: 8 AM on Day 1 (Baseline)
|
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp.
The cornea was divided into 5 different zones.
Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments.
Sum of scores of each zone led to total score.
Total score range: 0 to 15, higher score indicated greater staining.
Total corneal score from both study eye and fellow eye were reported.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
|
8 AM on Day 1 (Baseline)
|
Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35
Time Frame: 8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35
|
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp.
The cornea was divided into 5 different zones.
Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments.
Sum of scores of each zone led to total score.
Total score range: 0 to 15, higher score indicated greater staining.
Total corneal score from both study eye and fellow eye were reported.
Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'.
If both the measurements were equal, right eye was selected as the study eye.
The other eye was referred as 'fellow eye'.
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8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
July 6, 2009
First Submitted That Met QC Criteria
July 6, 2009
First Posted (ESTIMATE)
July 8, 2009
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 6, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0191002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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