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

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

Intervention: BOL-303259-X (Drug); Timolol (Drug); BOL-303259-X (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Jason Vittitow, Study Director, Affiliation: Bausch & Lomb Incorporated

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 3 months.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean IOP Reduction

Secondary outcome:

IOP ≤ 18 mm Hg

IOP reduction ≥ 25%

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

- 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).

Bausch & Lomb Inc., Rochester, New York 14609, United States

Starting date: January 2013
Last updated: August 21, 2014