Safety and IOP-Lowering Effects of WB007

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2022-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma, Primary Open Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant were aware of treatment assignment

Intervention Type DRUG

Timolol Maleate 0.5% Ophthalmic Solution

Interventions

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WB007 0.05%

WB007 Ophthalmic Solution 0.05%

Intervention Type DRUG

WB007 0.15%

WB007 Ophthalmic Solution 0.15%

Intervention Type DRUG

WB007 0.4%

WB007 Ophthalmic Solution 0.4%

Intervention Type DRUG

Timolol 0.5%

Timolol Maleate 0.5% Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No