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).

Bp Consulting

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndromes

Treatments

Drug: PEG- 400 based artificial tear

Drug: Systane

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00620893

5339

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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