Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223951
• Other study ID #: 05-003-10
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: February 19, 2015
• Start date: September 2005

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• R89674 (generic name not yet established)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No additional endpoints