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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04149899
Other study ID # WB007-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 14, 2019
Est. completion date December 14, 2022

Study information

Verified date April 2023
Source Whitecap Biosciences, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date December 14, 2022
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
WB007 0.05%
WB007 Ophthalmic Solution 0.05%
WB007 0.15%
WB007 Ophthalmic Solution 0.15%
WB007 0.4%
WB007 Ophthalmic Solution 0.4%
Timolol 0.5%
Timolol Maleate 0.5% Ophthalmic Solution

Locations

Country Name City State
United States Eye Research Foundation Newport Beach California

Sponsors (1)

Lead Sponsor Collaborator
Whitecap Biosciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Day 14
Secondary 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. Baseline, Day 14
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