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).

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bp Consulting, Inc
• Treatments: Lubricant Eye Drops

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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