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OpenTrials
Completed

NCT Number: NCT00702377

Evaluation of SYSTANE Ultra Lubricant Eye Drops

To evaluate the safety and efficacy of two artificial tears in 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

Primary location

Contact Call Center for Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented diagnosis of dry eyes
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion criteria

  • Age related

Treatment and study plan

Systane Ultra

Other

SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

Optive

Other

Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

Primary outcomes

  1. Tear Break-up Time

    Time frame: Day 0, Day 7, Day 14, Day 28, and Day 42

    Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.

  2. Conjunctival Staining

    Time frame: Day 0, Day 7, Day 14, Day 28, Day 42

    Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.

  3. Corneal Staining

    Time frame: Day 0, Day 7, Day 14, Day 28, Day 42

    Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
Feb 2, 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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