Safety and IOP-Lowering Effects of WB007

Bausch & Lomb Incorporated77 enrolled

Overview

The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glaucoma, Primary Open Angle Ocular Hypertension

Interventions

WB007 0.05%DRUG

WB007 Ophthalmic Solution 0.05%

WB007 0.15%DRUG

WB007 Ophthalmic Solution 0.15%

WB007 0.4%DRUG

WB007 Ophthalmic Solution 0.4%

Timolol 0.5%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 dilatation

Locations (1)

Eye Research Foundation

Newport Beach, California, United States

Outcomes

Primary Outcomes

Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye

IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary endpoint was the mean change from baseline IOP at Day 14, Hour 2, the timepoint of the peak effect of timolol.

Time frame: Baseline, Day 14

Secondary Outcomes

Part 2: Mean IOP at Day 14 - Study Eye

IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary timepoint was at Day 14, Hour 2, the timepoint of the peak effect of timolol.

Time frame: Baseline, Day 14

Data from ClinicalTrials.gov

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