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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01294956
First received: February 10, 2011
Last updated: November 17, 2016
Last verified: January 2012

February 10, 2011
November 17, 2016
January 2011
April 2011   (final data collection date for primary outcome measure)
Corneal Staining [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01294956 on ClinicalTrials.gov Archive Site
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A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Not Provided
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • Other: Lubricant Eye Drop
    1 drop in each eye, four times a day for 42 days
  • Other: Refresh Liquigel
    1 drop in each eye, four times a day for 42 days
  • Experimental: FID 115958D
    Lubricant Eye Drop
    Intervention: Other: Lubricant Eye Drop
  • Active Comparator: Refresh Liquigel
    Lubricant Eye Drop
    Intervention: Other: Refresh Liquigel
Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01294956
C-10-043
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP