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Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma Open-Angle Primary, Ocular Hypertension

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

H-1337 0.6%

H-1337 1.0%

H-1337 Placebo

Timolol 0.5%

About this trial

This is an interventional treatment trial for Glaucoma Open-Angle Primary

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of bilateral primary open angle glaucoma or ocular hypertension Exclusion Criteria: Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye Note: Other inclusion/exclusion criteria apply.

Sites / Locations

Global Research ManagementRecruiting
Central Florida Eye AssociatesRecruiting
Shettle Eye Research, Inc.Recruiting
Dixon Eye CareRecruiting
Coastal Research Associates, LLCRecruiting
Rochester Ophthalmological Group, PCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

H-1337 0.6% Ophthalmic Solution b.i.d.

H-1337 1.0% Ophthalmic Solution b.i.d.

H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.

Timolol 0.5% Ophthalmic Solution b.i.d.

Arm Description

One drop H-1337 twice daily in the study eye for 28 days

One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days

One drop Timolol twice daily in the study eye for 28 days

Outcomes

Primary Outcome Measures

Efficacy as Assessed by Change in Intraocular Pressure

Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol

Secondary Outcome Measures

Efficacy as Assessed by Intraocular Pressure

Mean intraocular pressure using Goldmann tonometry for each group compared to timolol

Safety as Assessed by Adverse Event Reporting

Incidence of ocular and systemic adverse events

Full Information

NCT ID

NCT05913232

First Posted

June 12, 2023

Last Updated

September 15, 2023

Sponsor

D. Western Therapeutics Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05913232

Brief Title

Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Official Title

A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 28, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

D. Western Therapeutics Institute, Inc.

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 trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 [0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.

6. Conditions and Keywords

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

Glaucoma Open-Angle Primary, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

H-1337 0.6% Ophthalmic Solution b.i.d.

Arm Type

Experimental

Arm Description

One drop H-1337 twice daily in the study eye for 28 days

Arm Title

H-1337 1.0% Ophthalmic Solution b.i.d.

Arm Type

Experimental

Arm Description

One drop H-1337 twice daily in the study eye for 28 days

Arm Title

H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.

Arm Type

Experimental

Arm Description

One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days

Arm Title

Timolol 0.5% Ophthalmic Solution b.i.d.

Arm Type

Active Comparator

Arm Description

One drop Timolol twice daily in the study eye for 28 days

Intervention Type

Drug

Intervention Name(s)

H-1337 0.6%

Intervention Description

ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

H-1337 1.0%

Intervention Description

ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

H-1337 Placebo

Intervention Description

ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Timolol 0.5%

Intervention Description

ophthalmic solution

Primary Outcome Measure Information:

Title

Efficacy as Assessed by Change in Intraocular Pressure

Description

Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Efficacy as Assessed by Intraocular Pressure

Description

Mean intraocular pressure using Goldmann tonometry for each group compared to timolol

Time Frame

Day 28

Title

Safety as Assessed by Adverse Event Reporting

Description

Incidence of ocular and systemic adverse events

Time Frame

Screening through Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DWTI CTA

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

El-Roy Dixon, MD

Organizational Affiliation

Dixon Eye Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Global Research Management

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

Facility Name

Central Florida Eye Associates

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

Facility Name

Shettle Eye Research, Inc.

City

Largo

State/Province

Florida

ZIP/Postal Code

33773

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

Facility Name

Dixon Eye Care

City

Albany

State/Province

Georgia

ZIP/Postal Code

31701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

Facility Name

Coastal Research Associates, LLC

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

Facility Name

Rochester Ophthalmological Group, PC

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

415-488-6849

dwticlinicaltrial@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

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