Back to resultsEfficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine, Refresh Plus
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry eye
Eligibility Criteria
Inclusion Criteria: Males or females > 18 years old 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: Prior use of topical cyclosporine within the last 1 year 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
Sites / Locations
- Southeastern Laser and Refractive Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Dry Eye Symptoms
Secondary Outcome Measures
Dry eye signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349440
Brief Title
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Official Title
Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cyclosporine, Refresh Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dry Eye Symptoms
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Dry eye signs
Time Frame
1.5 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females > 18 years old
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:
Prior use of topical cyclosporine within the last 1 year
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Stonecipher, MD
Organizational Affiliation
Southeastern Laser and Refractive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeastern Laser and Refractive Surgery
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
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