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).

Phase 4CompletedNCT00620893

Bp Consulting, Inc100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Dry Eye Syndromes

Interventions

PEG- 400 based artificial tearDRUG

Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily

SystaneDRUG

Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

dry eye signs

Time frame: 9 months

Secondary Outcomes

refractive regression

Time frame: 9 months

Data from ClinicalTrials.gov

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