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OpenTrials
Completed

NCT Number: NCT01223040

An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

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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

  • Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion criteria

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

Treatment and study plan

SYSTANE® BALANCE Lubricant Eye Drops

Other

Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.

Primary outcomes

  1. Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.

    Time frame: 8 days

Secondary outcomes

  1. Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8

    Time frame: 9 days

  2. Fluorescein staining at Visits 1 & 3 on the Ora staining scale

    Time frame: 9 days

  3. Ocular Symptomology at each visit

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Oct 18, 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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