Comparison of CL Wear Between Two Allergy Drops - Tabular View

Tracking Information

First Received Date ^ICMJE

June 19, 2007

Last Updated Date

June 20, 2007

Start Date ^ICMJE

July 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Contact lens objective and subjective clinical performance testing [ Time Frame: up to 3 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00489398 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison of CL Wear Between Two Allergy Drops

Official Title ^ICMJE

Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride

Brief Summary

Comparison of two allergy drops for enhancing comfort and performance of contact lens wear

Detailed Description

Contact lens patients will instill allergy drops and subjective and objective tests will be performed

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: epinastine HCL and olopatadine HCL

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

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males or females > 18 years old
Mild to moderate dry eye symptoms
Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

Current use of topical cyclosporine
Known contraindications to any study medication or ingredients
Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
Ocular surgery within the past 3 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Milton M Hom, OD FAAO

6269637100

eyemage@mminternet.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00489398

Responsible Party

Study ID Numbers ^ICMJE

5316

Study Sponsor ^ICMJE

Hom, Milton M., OD, FAAO

Collaborators ^ICMJE

Inspire Pharmaceuticals

Investigators ^ICMJE

Study Director:

Milton M Hom, OD FAAO

Private Practice

Information Provided By

Hom, Milton M., OD, FAAO

Verification Date

June 2007

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