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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: February 10, 2011
Last updated: November 17, 2016
Last verified: January 2012
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT01294956     History of Changes
Other Study ID Numbers: C-10-043
Study First Received: February 10, 2011
Last Updated: November 17, 2016

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 processed this record on September 21, 2017