Back to resultsA Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lubricant Eye Drop
Refresh Liquigel
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, artificial tears, corneal staining
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FID 115958D
Refresh Liquigel
Arm Description
Lubricant Eye Drop
Lubricant Eye Drop
Outcomes
Primary Outcome Measures
Corneal Staining
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294956
Brief Title
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, artificial tears, corneal staining
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FID 115958D
Arm Type
Experimental
Arm Description
Lubricant Eye Drop
Arm Title
Refresh Liquigel
Arm Type
Active Comparator
Arm Description
Lubricant Eye Drop
Intervention Type
Other
Intervention Name(s)
Lubricant Eye Drop
Intervention Description
1 drop in each eye, four times a day for 42 days
Intervention Type
Other
Intervention Name(s)
Refresh Liquigel
Intervention Description
1 drop in each eye, four times a day for 42 days
Primary Outcome Measure Information:
Title
Corneal Staining
Time Frame
Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
24403819
Citation
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. Epub 2013 Dec 31.
Results Reference
result
Learn more about this trial
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
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