Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Intraocular pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 420
Healthy volunteers: no

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:

Arms:
arm 1: BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). arm 2: Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).

Interventions: intervention 1: BOL-303259-X intervention 2: Timolol intervention 3: BOL-303259-X
Intervention descriptions: intervention 1: 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 2: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6) intervention 3: 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)

Protocol document: