Safety and IOP-Lowering Effects of WB007

NCT04149899 | Completed Phase 1 Results FDA Drug

• 1 other identifier: WB007-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Glaucoma, Primary Open Angle; Ocular Hypertension

Keywords

POAG; OHT; Primary open-angle glaucoma; ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Part 2: Mean IOP at Day 14 - Study Eye

  Baseline, Day 14

Study Arms (6)

Part 1 (Period 1): WB007 0.05%

EXPERIMENTAL

WB007 0.05%, single dose to study eye on Day 1

Drug: WB007 0.05%

Part 1 (Period 2): WB007 0.15%

EXPERIMENTAL

WB007 0.15%, single dose to study eye on Day 1

Drug: WB007 0.15%

Part 1 (Period 3): WB007 0.4%

EXPERIMENTAL

WB007 0.4%, single dose to study eye on Day 1

Drug: WB007 0.4%

Part 2: WB007 0.15%

EXPERIMENTAL

WB007 0.15%, dosed twice daily for 14 days

Drug: WB007 0.15%

Part 2: WB007 0.4%

EXPERIMENTAL

WB007 0.4%, dosed twice daily for 14 days

Drug: WB007 0.4%

Part 2: Timolol 0.5%

ACTIVE COMPARATOR

Timolol 0.5%, dosed twice daily for 14 days.

Drug: Timolol 0.5%

Interventions

WB007 0.05% DRUG

WB007 Ophthalmic Solution 0.05%

Part 1 (Period 1): WB007 0.05%

WB007 0.15% DRUG

WB007 Ophthalmic Solution 0.15%

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

WB007 0.4% DRUG

WB007 Ophthalmic Solution 0.4%

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

Timolol 0.5% DRUG

Timolol Maleate 0.5% Ophthalmic Solution

Part 2: Timolol 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ocular hypertension or primary open-angle glaucoma in each eye

You may not qualify if:

• History of orthostatic hypotension
• Any active ocular disease
• Anticipated wearing of contact lenses during study
• Contraindication to pupil dilatation

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Clinical Development
• Organization: Bausch & Lomb Incorporated

kevin.kerr@bausch.com

949-416-1194

Study Officials

• David Wirta, MD

  Eye Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant were aware of treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: November 14, 2019
• Primary Completion: January 31, 2021
• Study Completion: December 14, 2022
• Last Updated: March 27, 2025
• Results First Posted: March 24, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)