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).

NCT ID: NCT00620893

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-05-31

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

1\. PEG-400 based artificial tear

Group Type: ACTIVE_COMPARATOR

PEG- 400 based artificial tear

Intervention Type: DRUG

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

2

2\. Systane

Group Type: ACTIVE_COMPARATOR

Systane

Intervention Type: DRUG

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

Interventions

PEG- 400 based artificial tear

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

Intervention Type: DRUG

Systane

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bp Consulting, Inc

NETWORK

Sponsor Role: lead

Responsible Party

Weill Cornell Medical Center

Principal Investigators

Christopher Starr, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

5339

Identifier Type: -

Identifier Source: org_study_id