A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

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

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Documented diagnosis of dry eye
NaFl Corneal staining sum score ≥ 3 in either eye
Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion criteria

No contact lenses wear throughout the study period
Must not have had punctal plugs inserted within 30 days preceding enrollment

Treatment and study plan

Lubricant Eye Drop

Other

1 drop in each eye, four times a day for 42 days

Refresh Liquigel

Other

1 drop in each eye, four times a day for 42 days

Primary outcomes

Corneal Staining

Time frame: Day 42

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Feb 14, 2011
Registry last updated: Nov 18, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed