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NCT00244543 Clinical Trial

Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00244543
Other study ID # 05-003-13
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2005
Last updated September 26, 2011
Start date October 2005

Study information
Verified date September 2011
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 establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date
Est. primary completion date November 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years and older
Eligibility Inclusion Criteria:

history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction

Exclusion Criteria:

narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis

Study Design

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

Related Conditions & MeSH terms

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 Ocular itching and conjunctival redness post challenge
Secondary Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
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