Back to resultsEvaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
R89674 0.025% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring allergic conjunctivitis, ophthalmology, multicenter, controlled
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Ocular itching and redness scores at defined timepoints
Secondary Outcome Measures
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints
Full Information
NCT ID
NCT00364091
First Posted
August 11, 2006
Last Updated
September 26, 2011
Sponsor
Vistakon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00364091
Brief Title
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
allergic conjunctivitis, ophthalmology, multicenter, controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
R89674 0.025% ophthalmic solution
Primary Outcome Measure Information:
Title
Ocular itching and redness scores at defined timepoints
Secondary Outcome Measure Information:
Title
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD
Organizational Affiliation
Vistakon Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Louisville
State/Province
Kentucky
Country
United States
City
North Andover
State/Province
Massachusetts
Country
United States
City
Creve Coeur
State/Province
Missouri
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis
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