Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
621 participants
INTERVENTIONAL
2009-10-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Cyclosporine 0.005% eye drops
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Cyclosporine 0.005% eye drops
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Placebo (Vehicle for Cyclosporine)
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Placebo (Vehicle for Cyclosporine)
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Interventions
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Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Cyclosporine 0.005% eye drops
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Placebo (Vehicle for Cyclosporine)
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Eligibility Criteria
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Inclusion Criteria
* Patient is in good general health
* Eye glasses prescription of -1 to -8
Exclusion Criteria
* Presence of eye disease
* Uncontrolled systemic disease
* Previous use of RESTASIS®
21 Years
50 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Overland Park, Kansas, United States
Countries
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Other Identifiers
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192371-018
Identifier Type: -
Identifier Source: org_study_id
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