Safety and IOP-Lowering Effects of WB007

Phase 1

Completed

• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Interventions: Drug: Timolol 0.5%; Drug: WB007 0.05%; Drug: WB007 0.15%; Drug: WB007 0.4%

• Registration Number: NCT04149899
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Study Start: 2019-11-14
• Primary Completion: 2021-01-31
• Study Completion: 2022-12-14
• Results First Submitted: 2023-02-26
• Results First Submitted QC: 2023-02-26
• Results First Posted: 2023-03-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: Timolol 0.5%	Timolol 0.5%	Timolol 0.5%, dosed twice daily for 14 days.
Part 1 (Period 1): WB007 0.05%	WB007 0.05%	WB007 0.05%, single dose to study eye on Day 1
Part 1 (Period 2): WB007 0.15%	WB007 0.15%	WB007 0.15%, single dose to study eye on Day 1
Part 2: WB007 0.15%	WB007 0.15%	WB007 0.15%, dosed twice daily for 14 days
Part 1 (Period 3): WB007 0.4%	WB007 0.4%	WB007 0.4%, single dose to study eye on Day 1
Part 2: WB007 0.4%	WB007 0.4%	WB007 0.4%, dosed twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye	Baseline, Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Part 2: Mean IOP at Day 14 - Study Eye	Baseline, Day 14	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.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States