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CompletedNCT00348517Updated Mar 5, 2012

Safety/Efficacy of Systane Free vs Refresh Liquigel

An interventional study of Systane Free Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops in Dry Eye, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

02

Conditions studied

  • Dry Eye

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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 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

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

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
No

Inclusion criteria

  • >/= 3 corneal staining score using NEI scoring system.
  • Need artificial tears at least some of the time.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medication.
  • Use of Restasis within 30 days of Visit 1.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Systane

    Other: Systane Free Lubricant Eye Drops

  • Active comparator
    Refresh

    Other: Refresh Liquigel Lubricant Eye Drops

Interventions

  • OtherSystane Free Lubricant Eye Drops

    1-2 drops per eye four times per day for 42 days

  • OtherRefresh Liquigel Lubricant Eye Drops

    1-2 drops per eye four times per day for 42 days

06

What researchers measure

Primary outcomes

  1. Change in corneal staining at Day 28 from baseline (Day 0)

    Time frame: Day 28

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00348517
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jul 4, 2006
Start date
Jul 2006
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Mar 5, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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