CompletedPhase 1/2

Safety and IOP-Lowering Effects of WB007

United States77 participantsStarted 2019-11-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: Baseline, Day 14

Trial details

NCT IDNCT04149899

SponsorBausch & Lomb Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-31

Results submitted2023-02-26

View on ClinicalTrials.gov More Glaucoma, Primary Open Angle trials