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Prostaglandin Analog

H-1337 for Glaucoma

Phase 2

Recruiting

Led By El-Roy Dixon, MD

Research Sponsored by D. Western Therapeutics Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of 3 different eye drops for 28 days to see which works best.

Who is the study for?

This trial is for people with primary open angle glaucoma or ocular hypertension in both eyes. Participants must not have closed or very narrow angles in their eyes, as judged by an eye exam within the last 6 months.Check my eligibility

What is being tested?

The study tests three doses of H-1337 (0.6% twice daily, 1.0% twice daily, and 1.0% once a day) against Timolol (0.5%, twice daily). Each treatment will be given in both eyes for four weeks to see which is safer and more effective.See study design

What are the potential side effects?

Possible side effects may include discomfort in the eyes, redness, blurred vision, dryness or tearing up more than usual. Since it's a study drug, there might be unknown risks that will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with glaucoma or high eye pressure in both eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy as Assessed by Change in Intraocular Pressure

Secondary outcome measures

Efficacy as Assessed by Intraocular Pressure

Safety as Assessed by Adverse Event Reporting

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.Experimental Treatment2 Interventions

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

Group II: H-1337 1.0% Ophthalmic Solution b.i.d.Experimental Treatment1 Intervention

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

Group III: H-1337 0.6% Ophthalmic Solution b.i.d.Experimental Treatment1 Intervention

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

Group IV: Timolol 0.5% Ophthalmic Solution b.i.d.Active Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

H-1337 Placebo

2018

Completed Phase 2

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

D. Western Therapeutics Institute, Inc.Lead Sponsor

El-Roy Dixon, MDPrincipal InvestigatorDixon Eye Care

Media Library

H-1337 (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05913232 — Phase 2

Ocular Hypertension Research Study Groups: 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.

Ocular Hypertension Clinical Trial 2023: H-1337 Highlights & Side Effects. Trial Name: NCT05913232 — Phase 2

H-1337 (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05913232 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals still partake in this research study?

"According to clinicaltrials.gov, the recruitment phase of this research project has concluded; it began recruiting on September 1st 2023 and was last updated on June 12th 2023. However, there are still 917 active medical trials seeking participants at present."

Answered by AI

Do the risks outweigh the benefits of twice-daily use of H-1337 0.6% Ophthalmic Solution?

"H-1337 0.6% Ophthalmic Solution b.i.d has not been thoroughly tested in terms of efficacy, therefore it only recieved a score of 2 on the scale due to prior data demonstrating its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05913232.

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