Open-Label Study of Safety of H1337 in Healthy Volunteers

Phase 1

Completed

• Conditions: Glaucoma Open-Angle Primary; Ocular Hypertension
• Interventions: Drug: H-1337 1.0%

• Registration Number: NCT06572397
• Lead Sponsor: D. Western Therapeutics Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-27
• Study Start: 2024-09-16
• Status Verified: 2024-10
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-14
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H-1337 1.0% Ophthalmic Solution b.i.d.	H-1337 1.0%	One drop H-1337 twice daily in the both eyes for 7 days

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability]	Screening through Day 9	Incidence of ocular and systemic adverse events

Trial Locations

Locations (1)

Eye Research Foundation Inc.; 🇺🇸 Newport Beach, California, United States