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OpenTrials
Completed

NCT Number: NCT01252121

Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

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Key information

Conditions

Dry Eye Syndrome 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

  • Diagnosed with mild to moderate dry eye as defined in the protocol.
  • Able and willing to follow instructions.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any medical condition that may affect the results of the study.
  • History or evidence of ocular or intraocular surgery within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • Use of concomitant topical ocular medications during the study period.
  • Ocular conditions that may preclude safe administration of the test article.
  • Unwilling to discontinue contact lens wear during the study period.
  • Participation in an investigational drug or device study within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Systane Ultra Lubricant Eye Drops

Other

One drop in study eye, one time, during office visit.

Hialid 0.1 Artificial Tears Eye Drops

Other

One drop in study eye, one time, during office visit.

Unisol 4 Saline Solution

Other

One drop in study eye, one time, during office visit.

Primary outcomes

  1. Ocular surface residence time

    Time frame: Time to event

    Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2010
Registry last updated
Oct 30, 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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