search
Back to results

Evaluation of Efficacy of Ophthalmic Solution in Induced 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
Vistakon Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring ocular, allergic conjunctivitis, ophthalmic

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 25, 2005
Last Updated
September 26, 2011
Sponsor
Vistakon Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00244543
Brief Title
Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 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
110 (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
Accepts Healthy Volunteers
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
North Andover
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

We'll reach out to this number within 24 hrs