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

This study has been completed.
ClinicalTrials.gov Identifier:
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
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


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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
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