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Completed

NCT Number: NCT01160133

To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

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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

Primary location

Vasan Eye Care Hospital

Saidāpet, Channai, 600 015, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
  • A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
  • A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion criteria

  • A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
  • Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
  • A history of intolerance or hypersensitivity to any component of the study medications.

Treatment and study plan

Systane

Other

Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Refresh Tears

Other

Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Primary outcomes

  1. To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.

    Time frame: Baseline to visit 3 (Day 42)

    This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.

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Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2010
Registry last updated
Apr 10, 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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