Clinical trial

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

Name

WB007-001

Description

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.

Trial arms

Trial start

2019-11-14

Estimated PCD

2021-01-31

Trial end

2022-12-14

Status

Completed

Phase

Early phase I

Treatment

WB007 0.05%

WB007 Ophthalmic Solution 0.05%

Arms:

Part 1 (Period 1): WB007 0.05%

WB007 0.15%

WB007 Ophthalmic Solution 0.15%

Arms:

Part 1 (Period 2): WB007 0.15%, Part 2: WB007 0.15%

WB007 0.4%

WB007 Ophthalmic Solution 0.4%

Arms:

Part 1 (Period 3): WB007 0.4%, Part 2: WB007 0.4%

Timolol 0.5%

Timolol Maleate 0.5% Ophthalmic Solution

Arms:

Part 2: Timolol 0.5%

Size

Primary endpoint

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

Baseline, Day 14

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant were aware of treatment assignment', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 77, 'type': 'ACTUAL'}}

Updated at

2023-05-03

1 organization

2 products

3 indications

Product

WB007

Indication

Glaucoma

Indication

Primary Open-Angle Glaucoma

Indication

ocular hypertension

Organization

Whitecap Biosciences

Product

Timolol