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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294956
First Posted: February 14, 2011
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention
Dry Eye Other: Lubricant Eye Drop Other: Refresh Liquigel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Enrollment: 147
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01294956     History of Changes
Other Study ID Numbers: C-10-043
First Submitted: February 10, 2011
First Posted: February 14, 2011
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