Open-Label Study of Safety of H1337 in Healthy Volunteers

D. Western Therapeutics Institute, Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Open-Angle Primary Ocular Hypertension

Interventions

H-1337 1.0%DRUG

ophthalmic solution

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Eye Research Foundation Inc.

Newport Beach, California, United States

Outcomes

Primary Outcomes

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

Incidence of ocular and systemic adverse events

Time frame: Screening through Day 9

Data from ClinicalTrials.gov

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