Status:
COMPLETED
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).
Lead Sponsor:
Bp Consulting, Inc
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive regression in t...
Eligibility Criteria
Inclusion
- Patients ranging from normal to mild dry eye per physician assessment
- BCVA of 20/20
- Moderate to high myopia (-3 D to -10D of sphere)
- Patients who are scheduled to under go myopic bilateral LASIK with VISX laser
Exclusion
- Patients currently using topical cyclosporine
- Patients currently using Systane
- Patients currently using an oil-based artificial tear such as Soothe or Endura
- Any post-op epithelial defects or flap complications requiring further procedures (relifting, scraping, stretching etc.)
- DLK greater than stage 1 or infectious keratitis post-operatively
- Any uncontrolled systemic disease that may confound the results of this trial (Diabetes, Lupus, Rheumatoid Arthritis etc.)
- Anisometropia greater than 1D
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00620893
Start Date
February 1 2008
End Date
May 1 2009
Last Update
September 21 2009
Active Locations (1)
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1
Weill Cornell Medical Center
New York, New York, United States, 10021