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).

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 Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: PEG- 400 based artificial tear; Drug: Systane

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 1. PEG-400 based artificial tear	Drug: 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
Active Comparator: 2; 2. Systane	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
dry eye signs	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
refractive regression	9 months

Collaborators and Investigators

• Sponsor: Bp Consulting, Inc
• Investigators: Principal Investigator: Christopher Starr, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 22, 2008

Study Record Updates

• Last Update Posted (Estimate): September 21, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Dry eye signs and symptoms; refractive regression
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 5339