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CompletedNCT00620893Updated Sep 21, 2009

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).

A Phase 4 interventional study of PEG- 400 based artificial tear and Systane in Dry Eye Syndromes, sponsored by Bp Consulting, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-21.

Sponsored by Bp Consulting, Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Syndromes

Keywords

  • Dry eye signs and symptoms
  • refractive regression
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Bp Consulting, Inc is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    1

    1. PEG-400 based artificial tear

    Drug: PEG- 400 based artificial tear

  • Active comparator
    2

    2. Systane

    Drug: Systane

Interventions

  • DrugPEG- 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

  • DrugSystane

    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

06

What researchers measure

Primary outcomes

  1. dry eye signs

    Time frame: 9 months

Secondary outcomes

  1. refractive regression

    Time frame: 9 months

07

Study locations

1 site
  • Weill Cornell Medical Center
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00620893
Lead sponsor
Bp Consulting, Inc
First posted
Feb 22, 2008
Start date
Feb 2008
Primary completion
May 2009
Completion
May 2009
Last update
Sep 21, 2009

Study contacts

Christopher Starr, MD
principal investigator · Weill Medical College of Cornell University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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