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Completed

NCT Number: NCT01311609

A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

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Key information

Conditions

Moderate to Severe 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

About this study

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older, of both sexes, and any race.
  • Willing and able to make all required visits and follow study instructions.
  • A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during 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 > 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 daily (QID)]

Primary outcomes

  1. Corneal Staining

    Time frame: Visit 2 (Week 2) - change from baseline

  2. Best-corrected visual acuity

    Time frame: Visit 2 (Week 2) - change from baseline

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2011
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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