Open-Label Study of Safety of H1337 in Healthy Volunteers

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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Key information

Conditions

Glaucoma Open-Angle Primary Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eye Research Foundation Inc.

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Note: Other inclusion/exclusion criteria apply.

Treatment and study plan

H-1337 1.0%

Drug

ophthalmic solution

Primary outcomes

Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability]

Time frame: Screening through Day 9

Incidence of ocular and systemic adverse events

Sponsors and collaborators

Lead sponsor

D. Western Therapeutics Institute, Inc.

Industry

Registry information

Official study title

An Open-Label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of H1337 Ophthalmic Solution, 1% in Healthy Volunteers

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 27, 2024
Registry last updated: Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed