Open-Label Study of Safety of H1337 in Healthy Volunteers

D. Western Therapeutics Institute

Status and phase: Completed; Phase 1

Conditions: Glaucoma Open-Angle Primary; Ocular Hypertension

Treatments: Drug: H-1337 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06572397

H1337-CS101

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: H-1337 1.0%