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OpenTrials
Completed

NCT Number: NCT00348517

Safety/Efficacy of Systane Free vs Refresh Liquigel

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Systane Free Lubricant Eye Drops

Other

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

Refresh Liquigel Lubricant Eye Drops

Other

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

Primary outcomes

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

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

An Evaluation of the Safety and Efficacy of Systane Free FID 105783

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 4, 2006
Registry last updated
Mar 5, 2012

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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