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

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00611403

Purpose

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

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) Drug: Artificial Tears REFRESH ENDURA®	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
2: Placebo Comparator	Drug: Artificial Tears REFRESH ENDURA® REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611403

Locations

United States, Kansas

Overland Park, Kansas, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192371-014
Study First Received:	January 28, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00611403 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

LASIK

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Antifungal Agents
Eye Diseases
Lacrimal Apparatus Diseases

Dry Eye Syndromes
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Enzyme Inhibitors

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Syndrome
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 02, 2009