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).
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedSeptember 21, 2009
September 1, 2009
1.2 years
February 11, 2008
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
dry eye signs
9 months
Secondary Outcomes (1)
refractive regression
9 months
Study Arms (2)
1
ACTIVE COMPARATOR1\. PEG-400 based artificial tear
2
ACTIVE COMPARATOR2\. Systane
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical Center
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Starr, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 22, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
September 21, 2009
Record last verified: 2009-09