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

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ClinicalTrials.gov Identifier: NCT01294956
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Dry Eye Other: Lubricant Eye Drop Other: Refresh Liquigel

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2011
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: FID 115958D
Lubricant Eye Drop
Other: Lubricant Eye Drop
1 drop in each eye, four times a day for 42 days
Active Comparator: Refresh Liquigel
Lubricant Eye Drop
Other: Refresh Liquigel
1 drop in each eye, four times a day for 42 days

Outcome Measures

Primary Outcome Measures :
  1. Corneal Staining [ Time Frame: Day 42 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01294956     History of Changes
Other Study ID Numbers: C-10-043
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry eye
artificial tears
corneal staining

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Gastrointestinal Agents