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

Last updated: September 12, 2024
Sponsor: D. Western Therapeutics Institute, Inc.
Overall Status: Completed

Phase

2

Condition

Williams Syndrome

Vascular Diseases

Ocular Hypertension

Treatment

H-1337 1.0%

H-1337 Placebo

H-1337 0.6%

Clinical Study ID

NCT05913232
H1337-CS202
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Exclusion

Exclusion Criteria:

  • Closed or very narrow angles (Grades 0-1) or those the investigator judges asoccludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees bygonioscopy within 6 months prior to screening visit in either eye

Note: Other inclusion/exclusion criteria apply.

Study Design

Total Participants: 201
Treatment Group(s): 4
Primary Treatment: H-1337 1.0%
Phase: 2
Study Start date:
August 28, 2023
Estimated Completion Date:
August 29, 2024

Connect with a study center

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Skyline Vision Clinic and Laser Center

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Central Florida Eye Associates

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Shettle Eye Research, Inc.

    Largo, Florida 33773
    United States

    Site Not Available

  • Dixon Eye Care

    Albany, Georgia 31701
    United States

    Site Not Available

  • Coastal Research Associates, LLC

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Rochester Ophthalmological Group, PC

    Rochester, New York 14618
    United States

    Site Not Available

  • University Eye Specialists

    Maryville, Tennessee 37803
    United States

    Site Not Available

  • Vistar Eye Center

    Roanoke, Virginia 24011
    United States

    Site Not Available

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