Safety and IOP-Lowering Effects of WB007

Ocular Hypertension Clinical Trial

Official title:

A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149899
• Other study ID #: WB007-001
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Hypertension
• Ocular Hypertension

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