Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Information source: Allergan
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Eye Syndromes
Intervention: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) (Drug); Artificial Tears REFRESH ENDURA® (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
Summary
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion
administered twice daily following LASIK surgery
Clinical Details
Official title: Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: corneal sensitivity
Secondary outcome: contrast sensitivitySchirmer tear test
Eligibility
Minimum age: 21 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Overland Park, Kansas, United States; Recruiting
Additional Information
Starting date: December 2007
Ending date: April 2009
Last updated: May 5, 2008
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