Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

R89674 (generic name not yet established)

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

NCT ID

NCT00244543

First Posted

October 25, 2005

Last Updated

September 26, 2011

Sponsor

Vistakon Pharmaceuticals

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

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

Allergic Conjunctivitis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial