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OpenTrials
Completed

NCT Number: 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).

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medical Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG- 400 based artificial tear

Drug

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

Systane

Drug

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 outcomes

  1. dry eye signs

    Time frame: 9 months

Secondary outcomes

  1. refractive regression

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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