Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Phase 4
Completed
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: Cyclosporine, Refresh Plus
- Registration Number
- NCT00349440
- Lead Sponsor
- Innovative Medical
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cyclosporine, Refresh Plus - 2 Cyclosporine, Refresh Plus -
- Primary Outcome Measures
Name Time Method Dry Eye Symptoms 1.5 years
- Secondary Outcome Measures
Name Time Method Dry eye signs 1.5 yrs
Trial Locations
- Locations (1)
Southeastern Laser and Refractive Surgery
🇺🇸Greensboro, North Carolina, United States