Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

Phase 3CompletedNCT00223951

Vistakon Pharmaceuticals900 enrolled

Overview

The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

900

Conditions

Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Interventions

R89674 (generic name not yet established)DRUG

Eligibility

Sex: ALLMin age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better \- Exclusion Criteria: intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -

Locations (6)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Bel Air, Maryland, United States

Unnamed facility

North Andover, Massachusetts, United States

Unnamed facility

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination

Secondary Outcomes

No additional endpoints

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.