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OpenTrials
Completed

NCT Number: NCT01086774

Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

Evaluation of the optical effects of Systane Ultra

Completed

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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

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 years or more.
  • Subjects must have Tear Break Up Time (TBUT) < 5 seconds
  • Subjects must have a maximum blink interval (MBI) < 10 seconds
  • Subjects must be willing to comply with all study requirements.
  • Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion criteria

  • Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
  • Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
  • Subjects with known sensitivity to planned study concomitant medications
  • Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
  • Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Treatment and study plan

Systane Ultra Lubricant Eye Drops

Other

Single drop in both eyes

Primary outcomes

  1. Improvement in maximum blink interval (MBI)

    Time frame: 1 day

Secondary outcomes

  1. Tear film stability and contrast sensitivity

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Mar 15, 2010
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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