Safety and IOP-Lowering Effects of WB007

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: Timolol 0.5%; Drug: WB007 0.05%; Drug: WB007 0.15%; Drug: WB007 0.4%

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Part 2: Timolol 0.5%; Timolol 0.5%, dosed twice daily for 14 days.	Drug: Timolol 0.5%; Timolol Maleate 0.5% Ophthalmic Solution
Experimental: Part 1 (Period 1): WB007 0.05%; WB007 0.05%, single dose to study eye on Day 1	Drug: WB007 0.05%; WB007 Ophthalmic Solution 0.05%
Experimental: Part 1 (Period 2): WB007 0.15%; WB007 0.15%, single dose to study eye on Day 1	Drug: WB007 0.15%; WB007 Ophthalmic Solution 0.15%
Experimental: Part 1 (Period 3): WB007 0.4%; WB007 0.4%, single dose to study eye on Day 1	Drug: WB007 0.4%; WB007 Ophthalmic Solution 0.4%
Experimental: Part 2: WB007 0.15%; WB007 0.15%, dosed twice daily for 14 days	Drug: WB007 0.15%; WB007 Ophthalmic Solution 0.15%
Experimental: Part 2: WB007 0.4%; WB007 0.4%, dosed twice daily for 14 days	Drug: WB007 0.4%; WB007 Ophthalmic Solution 0.4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Whitecap Biosciences, LLC
• Investigators: Principal Investigator: David Wirta, MD, Eye Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: POAG; ocular hypertension; Primary open-angle glaucoma; OHT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol
• Other Study ID Numbers: WB007-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No