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

Tracking Information

First Received Date ^ICMJE

March 7, 2007

Last Updated Date

April 8, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Ocular itching

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00445874 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: Ketotifen with a Contact Lens (no generic name)

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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

History of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees withing 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 dyndrome
Ocular surgery within past 6 months
Pregnancy or lactation

Gender

Both

Ages

8 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00445874

Responsible Party

Study ID Numbers ^ICMJE

06-003-23

Study Sponsor ^ICMJE

Vistakon Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Brian Pall, OD, MS, FAAO

Vistakon Pharmaceutical

Information Provided By

Vistakon Pharmaceuticals

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP