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Open-Label Study of Safety of H1337 in Healthy Volunteers

NCT ID: NCT06572397

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2024-10-14

Brief Summary

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The trial will evaluate the safety of one dose regimen of H-1337 \[1% twice daily (b.i.d.)\] in both eyes in healthy volunteers.

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Detailed Description

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Conditions

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Glaucoma Open-Angle Primary Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

One drop H-1337 twice daily in the both eyes for 7 days

Group Type EXPERIMENTAL

H-1337 1.0%

Intervention Type DRUG

ophthalmic solution

Interventions

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H-1337 1.0%

ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult male or female subjects
* Subjects in good ocular and systemic health with clinically insignificant medical and ophthalmic history

Exclusion Criteria

* Chronic or acute ophthalmic disease in each eye including but not limited to any form of glaucoma, retinal diseases, clinically significant cataract (primary or secondary)
* Recent intraocular surgery in either eye (within 6 months)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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D. Western Therapeutics Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye Research Foundation Inc.

Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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H1337-CS101

Identifier Type: -

Identifier Source: org_study_id

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