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Safety and IOP-Lowering Effects of WB007

Primary Purpose

Glaucoma, Primary Open Angle, Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

WB007 0.05%

WB007 0.15%

WB007 0.4%

Timolol 0.5%

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle focused on measuring POAG, OHT, Primary open-angle glaucoma, ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Eye Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

Part 1 (Period 1): WB007 0.05%

Part 1 (Period 2): WB007 0.15%

Part 1 (Period 3): WB007 0.4%

Part 2: WB007 0.15%

Part 2: WB007 0.4%

Part 2: Timolol 0.5%

Arm Description

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

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

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

WB007 0.15%, dosed twice daily for 14 days

WB007 0.4%, dosed twice daily for 14 days

Timolol 0.5%, dosed twice daily for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04149899

First Posted

October 30, 2019

Last Updated

April 12, 2023

Sponsor

Whitecap Biosciences, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04149899

Brief Title

Safety and IOP-Lowering Effects of WB007

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 14, 2019 (Actual)

Primary Completion Date

January 31, 2021 (Actual)

Study Completion Date

December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Whitecap Biosciences, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Primary Open Angle, Ocular Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 (Period 1): WB007 0.05%

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1 (Period 2): WB007 0.15%

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1 (Period 3): WB007 0.4%

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2: WB007 0.15%

Arm Type

Experimental

Arm Description

WB007 0.15%, dosed twice daily for 14 days

Arm Title

Part 2: WB007 0.4%

Arm Type

Experimental

Arm Description

WB007 0.4%, dosed twice daily for 14 days

Arm Title

Part 2: Timolol 0.5%

Arm Type

Active Comparator

Arm Description

Timolol 0.5%, dosed twice daily for 14 days.

Intervention Type

Drug

Intervention Name(s)

WB007 0.05%

Intervention Description

WB007 Ophthalmic Solution 0.05%

Intervention Type

Drug

Intervention Name(s)

WB007 0.15%

Intervention Description

WB007 Ophthalmic Solution 0.15%

Intervention Type

Drug

Intervention Name(s)

WB007 0.4%

Intervention Description

WB007 Ophthalmic Solution 0.4%

Intervention Type

Drug

Intervention Name(s)

Timolol 0.5%

Intervention Description

Timolol Maleate 0.5% Ophthalmic Solution

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Day 14

Secondary Outcome Measure Information:

Title

Part 2: Mean IOP at Day 14 - Study Eye

Description

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.

Time Frame

Baseline, Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Wirta, MD

Organizational Affiliation

Eye Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye Research Foundation

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Safety and IOP-Lowering Effects of WB007

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