Clinical Trials Logo
  1. Home
  2. Ocular Hypertension
  3. NCT05913232
  4. Details
NCT05913232 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05913232
Other study ID # H1337-CS202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 28, 2023
Est. completion date December 2025

Study information
Verified date April 2024
Source D. Western Therapeutics Institute, Inc.
Contact DWTI CTA
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• H-1337 0.6%
ophthalmic solution
• H-1337 1.0%
ophthalmic solution
• H-1337 Placebo
ophthalmic solution
• Timolol 0.5%
ophthalmic solution

Locations
Country Name City State
United States Dixon Eye Care Albany Georgia
United States Skyline Vision Clinic and Laser Center Colorado Springs Colorado
United States Global Research Management Glendale California
United States Central Florida Eye Associates Lakeland Florida
United States Shettle Eye Research, Inc. Largo Florida
United States University Eye Specialists Maryville Tennessee
United States Vistar Eye Center Roanoke Virginia
United States Rochester Ophthalmological Group, PC Rochester New York
United States Coastal Research Associates, LLC Roswell Georgia

Sponsors (1)
Lead Sponsor Collaborator
D. Western Therapeutics Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy as Assessed by Change in Intraocular Pressure Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol Day 28
Secondary Efficacy as Assessed by Intraocular Pressure Mean intraocular pressure using Goldmann tonometry for each group compared to timolol Day 28
Secondary Safety as Assessed by Adverse Event Reporting Incidence of ocular and systemic adverse events Screening through Day 28
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2