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Safety and IOP-Lowering Effects of WB007

NCT04149899 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-03-27

Study results available
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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.

Conditions

Interventions

DRUG

WB007 0.05%

WB007 Ophthalmic Solution 0.05%

DRUG

WB007 0.15%

WB007 Ophthalmic Solution 0.15%

DRUG

WB007 0.4%

WB007 Ophthalmic Solution 0.4%

DRUG

Timolol 0.5%

Timolol Maleate 0.5% Ophthalmic Solution

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • David Wirta, MD · Eye Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2021-01-31
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149899 on ClinicalTrials.gov