Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 28 days.

• BL1107 Low dose (Drug): Dosed twice daily for 28 days.
• BL1107 High dose (Drug): Dosed twice daily for 28 days.
• Timolol maleate 0.5% (Drug): Dosed twice daily for 28 days.

Primary outcomes

• Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. [Assessed at Day 28]

Secondary outcomes

• Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. [Assessed at Day 28]
• Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. [Assessed at Day 28]
• Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit. [Assessed at Day 28]

Sex: All, ages: 18 Years to any

Inclusion criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion criteria:

* History of orthostatic hypotension
* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Contraindication to pupil dilation