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
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 |
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
Status | Completed |
Enrollment | 900 |
Est. completion date | |
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 - |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vistakon Pharmaceuticals |
United States,
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 |