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

NCT00611403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2011-12-20

Study results available
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Summary

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

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery

DRUG

Artificial Tears REFRESH ENDURA®

REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611403 on ClinicalTrials.gov