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).

• Sponsor: Bp Consulting, Inc (Other)
• Overall Status: Completed
• CT.gov ID: NCT00620893
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: PEG- 400 based artificial tear; Drug: Systane	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. dry eye signs [9 months]

Secondary Outcome Measures

1. refractive regression [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical Center	New York	New York	United States	10021

Sponsors and Collaborators

• Bp Consulting, Inc

Investigators

• Principal Investigator: Christopher Starr, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00620893
• Other Study ID Numbers: 5339
• First Posted: Feb 22, 2008
• Last Update Posted: Sep 21, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Dry eye signs and symptoms; refractive regression
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lubricant Eye Drops

Study Results

No Results Posted as of Sep 21, 2009