- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01223378
Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension (Voyager)
June 27, 2018 updated by: Bausch & Lomb Incorporated
A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension
The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
413
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
-
-
New York
-
Rochester, New York, United States, 14609
- Bausch & Lomb, Inc
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
- IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
- Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.
Exclusion Criteria:
- Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- Subjects with known contraindications to nitric oxide (NO) treatment.
- Subjects whose central corneal thickness was greater than 600um in either eye.
- Subjects with any condition that prevented reliable applanation tonometry in either eye.
- Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
- Subjects with previous or active corneal disease.
- Subjects with a history of severe dry eye.
- Subjects with monophthalmia.
- Subjects with optic disc hemorrhage.
- Subjects with a history of central retinal vein and artery occlusion.
- Subjects with a history of macular edema.
- Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
- Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
- Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
- Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
- Subjects who were expected to require treatment with ocular or systemic corticosteroids.
- Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
- Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BOL-303259-X
ophthalmic solution
|
ophthalmic solution, various concentrations, once daily (QD) 28 days
Other Names:
|
Active Comparator: Latanoprost
ophthalmic solution
|
0.005% ophthalmic solution, QD 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Diurnal IOP at Visit 6 (Day 28)
Time Frame: Baseline and Visit 6 (Day 28)
|
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
|
Baseline and Visit 6 (Day 28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Diurnal IOP at Visits 4,5, and 7
Time Frame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
|
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
|
Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
|
IOP </=18mm Hg
Time Frame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
|
Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution
|
Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
|
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
Time Frame: baseline and Visit 6 (Day 28)
|
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
|
baseline and Visit 6 (Day 28)
|
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
Time Frame: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)
|
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
|
baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rabia Ozden, MD, Bausch & Lomb Incorporated
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 (Actual)
December 13, 2010
Primary Completion (Actual)
December 20, 2011
Study Completion (Actual)
June 22, 2012
Study Registration Dates
First Submitted
October 11, 2010
First Submitted That Met QC Criteria
October 15, 2010
First Posted (Estimate)
October 19, 2010
Study Record Updates
Last Update Posted (Actual)
July 24, 2018
Last Update Submitted That Met QC Criteria
June 27, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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