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

NCT05913232 | Completed Phase 2 Results FDA Drug

• 1 other identifier: H1337-CS202
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 9

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.

Conditions

Glaucoma Open-Angle Primary; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Efficacy as Assessed by Change in Intraocular Pressure

  Mean change in intraocular pressure from baseline on Day 28 compared to timolol

  Day 28

Secondary Outcomes (2)

• Efficacy as Assessed by Intraocular Pressure

  Day 0, Day 1, Day 7, Day 14, and Day 28

• Safety as Assessed by Adverse Event Reporting

  Screening through Day 28

Study Arms (4)

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

EXPERIMENTAL

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

Drug: H-1337 0.6%

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

EXPERIMENTAL

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

Drug: H-1337 1.0%

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

EXPERIMENTAL

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

Drug: H-1337 1.0%; Drug: H-1337 Placebo

Timolol 0.5% Ophthalmic Solution b.i.d.

ACTIVE COMPARATOR

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

Drug: Timolol 0.5%

Interventions

H-1337 0.6% DRUG

ophthalmic solution

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

H-1337 1.0% DRUG

ophthalmic solution

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.

H-1337 Placebo DRUG

ophthalmic solution

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

Timolol 0.5% DRUG

ophthalmic solution

Timolol 0.5% Ophthalmic Solution b.i.d.

Eligibility Criteria

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

You may qualify if:

• Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• D. Western Therapeutics Institute, Inc.: lead

Study Sites (9)

Global Research Management

Glendale, California, 91204, United States

Location

Skyline Vision Clinic and Laser Center

Colorado Springs, Colorado, 80907, United States

Location

Central Florida Eye Associates

Lakeland, Florida, 33805, United States

Location

Shettle Eye Research, Inc.

Largo, Florida, 33773, United States

Location

Dixon Eye Care

Albany, Georgia, 31701, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

Vistar Eye Center

Roanoke, Virginia, 24011, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Limitations and Caveats

No significant limitations or caveats were reported for the study.

Results Point of Contact

• Title: Shigenobu Nakazora
• Organization: D. Western Therapeutics Institute, Inc.

shinakazora@dwti.co.jp

+81-52-218-8785

Study Officials

• El-Roy Dixon, MD

  Dixon Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: August 28, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)