Back to resultsEvaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
R89674 (generic name not yet established)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring ocular, allergic conjunctivitis, ophthalmic
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Ocular itching and conjunctival redness post challenge
Secondary Outcome Measures
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
Full Information
NCT ID
NCT00241319
First Posted
October 14, 2005
Last Updated
September 26, 2011
Sponsor
Vistakon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00241319
Brief Title
Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2005 (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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
ocular, allergic conjunctivitis, ophthalmic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
R89674 (generic name not yet established)
Primary Outcome Measure Information:
Title
Ocular itching and conjunctival redness post challenge
Secondary Outcome Measure Information:
Title
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingerman Avner, MD
Organizational Affiliation
Johnson & Johnson
Official's Role
Study Director
Facility Information:
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lewiston
State/Province
Maine
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
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Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
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