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).

Completed · Phase 4

Conditions studied: Dry Eye Syndromes

In brief

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 these patients. The 'Refractive Outcome' data point will be defined as the difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.

Key facts

Study ID

NCT00620893

Run by

Bp Consulting, Inc

People needed

100

Starts

2008-02-01

Expected to finish

2009-05-01

Last updated by the study team

2009-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.