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Study of Cyclosporine in Post-LASIK Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00991458
First received: October 7, 2009
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  Purpose

This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.


Condition Intervention Phase
Laser In Situ Keratomileusis
 Drug: Cyclosporine 0.005% eye drops
Drug: Cyclosporine 0.010% eye drops
Drug: Vehicle for Cyclosporine
 Phase 2

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: Study of Cyclosporine in Post-LASIK Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Corneal sensitivity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tear Film Assessment [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Poor vision [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment: 621
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclosporine 0.005% eye drops
Cyclosporine 0.005% eye drops
 Drug: Cyclosporine 0.005% eye drops
Administer 1 drop to each eye twice daily (BID)
Experimental: Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye drops
 Drug: Cyclosporine 0.010% eye drops
Administer 1 drop to each eye twice daily (BID)
Placebo Comparator: Placebo
Vehicle for Cyclosporine
 Drug: Vehicle for Cyclosporine
Administer 1 drop to each eye twice daily (BID)

  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
  • Previous use of RESTASIS®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991458

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: NCT00991458     History of Changes
Other Study ID Numbers: 192371-018
Study First Received: October 7, 2009
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tetrahydrozoline
Cyclosporins
Cyclosporine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013