- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02358369
Dose-Ranging Study of the Bimatoprost Ocular Insert
A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.
This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
- Vold Vision
-
-
California
-
Artesia, California, United States, 90701
- Sall Medical Research Center
-
Newport Beach, California, United States, 92663
- Eye Research Foundation
-
-
Georgia
-
Morrow, Georgia, United States, 30260
- Clayton Eye Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Mundorf Eye Center
-
High Point, North Carolina, United States, 27262
- Cornerstone Health Care
-
-
Ohio
-
Madeira, Ohio, United States, 45243
- Apex Eye
-
-
Tennessee
-
Maryville, Tennessee, United States, 37803
- University of Eye Specialists
-
Memphis, Tennessee, United States, 38119
- Total Eye Care
-
-
Texas
-
San Antonio, Texas, United States, 78229
- R&R Eye Research, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Written informed consent
- At least 18 years of age
- Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
- Best corrected-distance visual acuity score equivalent to 20/80 or better
- Stable visual field
- Central corneal thickness between 490 - 620 micrometers
Inclusion Criteria at the Randomization Visit:
("T" is defined as time and "hr" is defined as hour[s])
- IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
- Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
- IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.
Key Exclusion Criteria:
- Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
- A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
- Cup-to-disc ratio of greater than 0.8
- Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
- Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
- Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
- Past history of any incisional surgery for glaucoma at any time
- Past history of corneal refractive surgery
- Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
- Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
- Inability to adequately evaluate the retina
- Participants who will require contact lens use during the study period.
- Participants who currently have punctal occlusion
- Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 13 mg Bimatoprost Ocular Insert
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks.
Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks.
After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
|
Bimatoprost sustained release Ocular Insert
Placebo ocular insert OU.
Placebo eye drops BID OU.
|
Experimental: 2.2 mg Bimatoprost Ocular Insert
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks.
After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
|
Bimatoprost sustained release Ocular Insert
Placebo ocular insert OU.
Placebo eye drops BID OU.
|
Active Comparator: Timolol 0.5%
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. |
Bimatoprost sustained release Ocular Insert
Placebo ocular insert OU.
BID drops OU, 0.5% ophthalmic solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Intraocular Pressure (IOP) at Week 8
Time Frame: Baseline (Day 0) to Week 8
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
|
Baseline (Day 0) to Week 8
|
Change From Baseline in IOP at Week 12
Time Frame: Baseline (Day 0) to Week 12
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
|
Baseline (Day 0) to Week 12
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Time Frame: Baseline (Day 0) to Week 8
|
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
An increase in the number of letters read correctly means that vision has improved.
|
Baseline (Day 0) to Week 8
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Time Frame: Baseline (Day 0) to Week 12
|
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
An increase in the number of letters read correctly means that vision has improved.
|
Baseline (Day 0) to Week 12
|
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
Time Frame: Baseline (Day 0) to Week 12
|
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination).
Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
|
Baseline (Day 0) to Week 12
|
Change From Baseline in Automated Visual Field at Week 12
Time Frame: Baseline (Day 0) to Week 12
|
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point.
A positive change from Baseline indicates improvement.
|
Baseline (Day 0) to Week 12
|
Dilated Fundus Exam: Cup-to-Disc-Ratio
Time Frame: Week 12
|
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma.
The diameter of the cup is compared to the diameter of the disk and a ratio is determined.
The normal cup-disk ratio is 0.3.
An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
|
Week 12
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Time Frame: Week 12
|
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3).
The percentage of participants in each grade is reported.
|
Week 12
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Time Frame: Baseline (Day 0) to Week 12
|
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study.
An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye.
Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
|
Baseline (Day 0) to Week 12
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Time Frame: Week 12 to Week 24
|
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study.
An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye.
The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
|
Week 12 to Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in IOP at Week 2
Time Frame: Baseline (Day 0) to Week 2
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
|
Baseline (Day 0) to Week 2
|
Change From Baseline in IOP at Week 6
Time Frame: Baseline (Day 0) to Week 6
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
|
Baseline (Day 0) to Week 6
|
Change From Baseline in IOP in Period C
Time Frame: Baseline (Day 0) to Weeks 14, 18 and 24
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24.
IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
|
Baseline (Day 0) to Weeks 14, 18 and 24
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Pharmaceutical Solutions
- Timolol
- Ophthalmic Solutions
- Bimatoprost
Other Study ID Numbers
- FSV5-004
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.
Clinical Trials on Ocular Hypertension
-
Western Galilee Hospital-NahariyaUnknown
-
Laboratoires TheaCompletedOcular Hypertension GlaucomaBulgaria
-
West Virginia UniversityUniversity of PittsburghRecruitingGlaucoma and Ocular HypertensionUnited States, United Kingdom, Canada
-
Santen Inc.Completed
-
University Hospital, GenevaTerminatedGlaucoma and Ocular HypertensionSwitzerland
-
Santen Inc.Completed
-
Maastricht University Medical CenterCompletedCorticosteroid Induced Ocular Hypertension/GlaucomaNetherlands
-
Santen Inc.CompletedA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHTGlaucoma and Ocular HypertensionUnited States
-
Bausch & Lomb IncorporatedCompletedGlaucoma | Open Angle or Ocular HypertensionUnited States
-
Nicox Ophthalmics, Inc.CompletedGlaucoma, Open-Angle | Hypertension, OcularUnited States
Clinical Trials on Bimatoprost
-
AllerganCompletedAlopecia | Alopecia, Androgenetic | BaldnessUnited States
-
AllerganCompletedAlopecia | Alopecia, Androgenetic | BaldnessUnited States
-
AllerganCompletedOcular Hypertension | Open-Angle GlaucomaUnited States, Israel, Canada, Singapore, Philippines, Spain, Australia, Belgium, Brazil, Germany
-
AllerganCompletedIdiopathic Eyelash HypotrichosisRussian Federation, Sweden, United States, United Kingdom
-
AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleUnited States
-
Kenneth BeerAllerganCompleted
-
AllerganCompletedAndrogenetic AlopeciaUnited States
-
AllerganCompletedAlopecia | BaldnessUnited States, Germany
-
AbbVieActive, not recruitingOcular Hypertension | Open-Angle GlaucomaUnited States, Argentina, Australia, Bulgaria, Czechia, Denmark, Germany, Hungary, Ireland, Italy, New Zealand, Poland, Russian Federation, South Africa, Sweden, United Kingdom
-
AllerganCompletedEyelash HypotrichosisJapan