Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:

A Multi-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: NCT00241319
• Other study ID #: 05-003-11
• Status: Completed
• Phase: Phase 3
• First received: October 14, 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: 150
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• 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

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

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