Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
NCT ID: NCT00349440
Last Updated: 2008-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
2
Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Interventions
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Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Eligibility Criteria
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Inclusion Criteria
* Mild-moderate symptoms of dry eye prior to surgery
* Scheduled to undergo bilateral LASIK or PRK
* Likely to complete all study visits and able to provide informed consent
Exclusion Criteria
* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Ocular disorders
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
18 Years
ALL
No
Sponsors
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Innovative Medical
INDUSTRY
Responsible Party
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Southeastern Laser and Refractive Surgery
Principal Investigators
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Karl Stonecipher, MD
Role: PRINCIPAL_INVESTIGATOR
Southeastern Laser and Refractive Surgery
Locations
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Southeastern Laser and Refractive Surgery
Greensboro, North Carolina, United States
Countries
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Other Identifiers
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1121
Identifier Type: -
Identifier Source: org_study_id