A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers

Vistakon Pharmaceuticals0 sites900 target enrollmentSeptember 2005

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

DrugsR89674 (generic name not yet established)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
Sponsor: Vistakon Pharmaceuticals
Enrollment: 900
Primary Endpoint: 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
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

December 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vistakon Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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 -

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