Glaucoma
Conditions
Brief summary
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
Detailed description
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.
Interventions
DRUGBL1107 Low dose
Dosed twice daily for 28 days.
DRUGBL1107 High dose
Dosed twice daily for 28 days.
Dosed twice daily for 28 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. | Assessed at Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTJohnson Varughese
Outcome results
None listed