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 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: PEG- 400 based artificial tear; Drug: Systane

• Registration Number: NCT00620893
• Lead Sponsor: Bp Consulting, Inc

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-22
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PEG- 400 based artificial tear	1. PEG-400 based artificial tear
2	Systane	2. Systane

Primary Outcome Measures

Name	Time	Method
dry eye signs	9 months

Secondary Outcome Measures

Name	Time	Method
refractive regression	9 months

Trial Locations

Locations (1)

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States