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).

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620893
• Other study ID #: 5339
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2008
• Last updated: September 17, 2009
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dry eye signs		9 months	No
Secondary	refractive regression		9 months	No