Back to resultsBilateral, 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).
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PEG- 400 based artificial tear
Systane
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry eye signs and symptoms, refractive regression
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
1. PEG-400 based artificial tear
2. Systane
Outcomes
Primary Outcome Measures
dry eye signs
Secondary Outcome Measures
refractive regression
Full Information
NCT ID
NCT00620893
First Posted
February 11, 2008
Last Updated
September 17, 2009
Sponsor
Bp Consulting, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00620893
Brief Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bp Consulting, Inc
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye signs and symptoms, refractive regression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
1. PEG-400 based artificial tear
Arm Title
2
Arm Type
Active Comparator
Arm Description
2. Systane
Intervention Type
Drug
Intervention Name(s)
PEG- 400 based artificial tear
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Systane
Intervention Description
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
Primary Outcome Measure Information:
Title
dry eye signs
Time Frame
9 months
Secondary Outcome Measure Information:
Title
refractive regression
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Starr, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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).
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