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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
Sponsor:
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
Criteria

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

Publications:
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
Tetrahydrozoline
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents