Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

September 26, 2011 updated by: Vistakon Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maine
      • Lewiston, Maine, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ocular itching and conjunctival redness post challenge

Secondary Outcome Measures

Outcome Measure
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vistakon Pharmaceuticals

Investigators

  • Study Director: Ingerman Avner, MD, Johnson & Johnson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-003-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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