Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364091
• Other study ID #: 06-003-09
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2006
• Last updated: September 26, 2011
• Start date: August 2006

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 summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• history of positive diagnostic test for ragweed within the past 2 years;

• positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion Criteria:

• ocular infection;

• history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;

• moderate to severe asthma;

• dry eye syndrome;

• history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;

• pregnancy or lactation

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 0.025% ophthalmic solution

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 redness scores at defined timepoints
Secondary	QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints