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: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 10, 2011
Last Updated Date	January 31, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 11, 2011)	Corneal Staining [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01294956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	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
Study Arm (s)	Experimental: FID 115958D Lubricant Eye Drop Intervention: Other: Lubricant Eye Drop Active Comparator: Refresh Liquigel Lubricant Eye Drop Intervention: Other: Refresh Liquigel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	147
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01294956
Other Study ID Numbers ^ICMJE	C-10-043
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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