Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 4, 2007

Last Updated Date

April 8, 2009

Start Date ^†

January 2007

Current Primary Outcome Measures ^†

Ocular itching

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00432757 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis

Official Title ^†

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Allergic Conjunctivitis

Intervention ^†

Drug: Ketotifen with a Contact Lens (generic name not yet established)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

120

Completion Date

March 2007

Primary Completion Date

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; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation

Gender

Both

Ages

8 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00432757

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Vistakon Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Brian Pall, OD, MS, FAAO

Vistakon Pharmaceuticals

Information Provided By

Vistakon Pharmaceuticals

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.