Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: BOL-303259-X; Drug: Timolol

• Registration Number: NCT01749904
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Study Start: 2013-01-31
• Primary Completion: 2015-06-02
• Study Completion: 2015-09-30
• Results First Submitted: 2018-05-01
• Status Verified: 2018-08
• Results First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Results First Posted: 2018-11-07
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.
• Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
• Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
• Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
• Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
• Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOL-303259-X	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).
Timolol	Timolol	Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol	BOL-303259-X	Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).

Primary Outcome Measures

Name	Time	Method
Mean IOP	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 Outcome Measures

Name	Time	Method
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).	Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
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).	Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months

Trial Locations

Locations (1)

Bausch & Lomb Inc.; 🇺🇸 Rochester, New York, United States