Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
This study is ongoing, but not recruiting participants.
First Received: January 28, 2008   Last Updated: January 13, 2009   History of Changes
Sponsor: 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

Additional relevant MeSH terms:
Anti-Infective Agents
Disease
Cyclosporine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Enzyme Inhibitors
Dry Eye Syndromes
 Immunosuppressive Agents
Cyclosporins
Pharmacologic Actions
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services