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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

BOL-303259-X

Intervention Type DRUG

Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).

BOL-303259-X

Intervention Type DRUG

All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)

Timolol

Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).

Group Type ACTIVE_COMPARATOR

Timolol

Intervention Type DRUG

Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)

BOL-303259-X

Intervention Type DRUG

All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)

Interventions

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BOL-303259-X

Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).

Intervention Type DRUG

Timolol

Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)

Intervention Type DRUG

BOL-303259-X

All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No