Safety and IOP-Lowering Effects of WB007
Study Details
Study Description
Brief Summary
To evaluate the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a 2-part study. Part 1 will look at up to 3 formulations of WB007 ophthalmic solution following a single dose in one eye. Part 2 will look at up to 2 formulations of WB007 (to be selected based on results from Part 1) in both eyes compared with timolol 0.5% for 14 days.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Study Treatment 1 WB007 Formulation 1 |
Drug: Study Treatment 1 WB007
Dosed for 14 days in both eyes
Other Names:
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Experimental: Study Treatment 2 WB007 Formulation 2 |
Drug: Study Treatment 2 WB007
Dosed for 14 days in both eyes
Other Names:
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Experimental: Study Treatment 3 WB007 Formulation 3 |
Drug: Study Treatment 3 WB007
Dosed for 14 days in both eyes
Other Names:
|
Active Comparator: Timolol 0.5% Timolol maleate ophthalmic solution, 0.5% |
Drug: Timolol 0.5%
Dosed for 14 days in both eyes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean change from Baseline in intraocular pressure (IOP) at Day 14 [Baseline, Day 14]
IOP measured by Goldmann applanation tonometry
Secondary Outcome Measures
- Mean IOP at Day 14 [Baseline, Day 14]
IOP measured by Goldmann applanation tonometry
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Eye Research Foundation | Newport Beach | California | United States | 92663 |
Sponsors and Collaborators
- Whitecap Biosciences, LLC
Investigators
- Principal Investigator: David Wirta, MD, Eye Research Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WB007-001