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Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00627302
Enrollment
40
Registered
2008-03-03
Start date
2008-02-29
Completion date
2008-11-30
Last updated
2008-11-24

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

Conditions

Myopia

Keywords

Quality of Vision

Brief summary

To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.

Interventions

DRUGPEG-400

Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily

Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily

Sponsors

Bp Consulting, Inc
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Males or females \> 21 years old * Scheduled to undergo bilateral LASIK * Likely to complete all study visits and able to provide informed consent

Exclusion criteria

* Prior or current use of topical cyclosporine within the last 1 year * Known contraindications to any study medication or ingredients * Ocular disorders * Active ocular diseases or uncontrolled systemic disease * Active ocular allergies * Complications at the time of surgery

Design outcomes

Primary

MeasureTime frame
Quality of vision5 months

Secondary

MeasureTime frame
Efficacy5 months

Countries

United States

Outcome results

None listed

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