Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

Phase 3

Completed

• Conditions: Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

• Registration Number: NCT00223951
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2005-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
No additional endpoints