A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Overview
- Phase
- Phase 3
- Intervention
- BOL-303259-X
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Mean IOP
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
- •Participants must meet the following IOP requirements at Visit 3
- •mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
- •IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
- •Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.
Exclusion Criteria
- •Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
- •Participants with a central corneal thickness greater than 600 μm in either eye.
- •Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
- •Participants who do not have an intact posterior capsule in either eye .
- •Participants with aphakia in either eye.
- •Participants with previous or active corneal disease in either eye.
- •Participants with current or a history of severe dry eye in either eye.
- •Participants with current or a history of optic disc hemorrhage in either eye.
- •Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
- •Participants with current or a history of macular edema in either eye.
Arms & Interventions
BOL-303259-X
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
Intervention: BOL-303259-X
Timolol
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Intervention: Timolol
Timolol
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Intervention: BOL-303259-X
Outcomes
Primary Outcomes
Mean IOP
Time Frame: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Secondary Outcomes
- Response Rate - IOP ≤ 18 mm Hg(8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).)
- Response Rate - IOP Reduction ≥ 25%(8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).)