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).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620893

Enrollment

100

Registered

2008-02-22

Start date

2008-02-29

Completion date

2009-05-31

Last updated

2009-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye signs and symptoms, refractive regression

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* 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

Design outcomes

Primary

Measure	Time frame
dry eye signs	9 months

Secondary

Measure	Time frame
refractive regression	9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026