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 (LUNAR)

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: BOL-303259-X; Drug: Timolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01749930

770

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups

BOL-303259-X

Experimental group

Description:

BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).

Treatment:

Drug: BOL-303259-X

Drug: BOL-303259-X

Timolol

Active Comparator group

Description:

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

Treatment:

Drug: BOL-303259-X

Drug: BOL-303259-X

Drug: Timolol