Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

January 28, 2008

Last Updated Date

January 13, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

corneal sensitivity [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00611403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

contrast sensitivity [ Time Frame: Months 1-6 ] [ Designated as safety issue: No ]
Schirmer tear test [ Time Frame: Months 1-6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Official Title ^ICMJE

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Brief Summary

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dry Eye Syndromes

Intervention ^ICMJE

Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Drug: Artificial Tears REFRESH ENDURA®

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient is scheduled for bilateral LASIK surgery
Patient is in good general health
Eye glasses prescription of -1 to -8

Exclusion Criteria:

Significant Dry Eye
Presence of eye disease
Uncontrolled systemic disease

Gender

Both

Ages

21 Years to 50 Years

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

NCT00611403

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

192371-014

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

January 2009

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