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

Sponsor:	Allergan
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Resource links provided by NLM:

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Patients With Clinical Success at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

Secondary Outcome Measures:

Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).
Change From Baseline in Goblet Cell Density of the Eyes at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).

Enrollment:	137
Study Start Date:	December 2007
Study Completion Date:	June 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00611403 History of Changes
Other Study ID Numbers:	192371-014
Study First Received:	January 28, 2008
Results First Received:	November 17, 2011
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

LASIK

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012