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).

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00620893
First received: February 11, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Dry Eye Syndromes
Drug: PEG- 400 based artificial tear
Drug: Systane
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • dry eye signs [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • refractive regression [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620893

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: Dr. Christopher Starr, Weill Cornell Medical Center
ClinicalTrials.gov Identifier: NCT00620893     History of Changes
Other Study ID Numbers: 5339
Study First Received: February 11, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Bp Consulting, Inc:
Dry eye signs and symptoms
refractive regression

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014