NCT00620893

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).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Bp Consulting, Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-22
• Last updated: 2009-09-21

Locations

1 site across 1 country: United States