Back to resultsEfficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
carboxymethylcellulose
xanthan gum
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Ocular Surface Disease Index > 12<23 and age >59 yrs
Exclusion Criteria:
- contact lens wear and use of other ophthalmic solutions with the exception of artificial tears
Sites / Locations
- University of Messina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
carboxymethylcellulose
xanthan gum
Arm Description
1 drop in each eye four times a day for 30 days
1 drop in each eye four times a day for 30 days
Outcomes
Primary Outcome Measures
Ocular surface disease index (OSDI)
OSDI is a questionnaire including 12 questions to be asked to the patient. From the questionnaire it will be possible to calculate the OSDI score which is a reliable and valid measurement for dry eye severity.
Secondary Outcome Measures
Visual analogue rating scale (VARS)
Global symptoms of dry eye will be graded by patients using a 0-100 mm visual analogue rating scale (0 = no symptoms to 100 = severe symptoms)
Fluorescein staining
Eye surface damage (corneal and conjunctival) assessed by fluorescein staining will be graded against standard chart (Oxford system)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01959854
Brief Title
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
Official Title
Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SIFI SpA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2% xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of oxidative stress.
Detailed Description
Oxidative stress is the result of an imbalance between the production of reactive oxygen species (ROS) and antioxidant systems . The eye is constantly exposed to solar UV radiation which is the major inducer of ROS production and therefore oxidative stress has been implicated in the pathogenesis of several eye disease, including dry eye. Xanthan gum is a complex exopolysaccharide utilized as a food additive. Its chemical structure shows a capacity to react with ROS indicating a role as an anti-oxidative molecule.
In the present study aging patients with dry eye will be enrolled. Signs and symptoms of dry eye as well as levels of oxidative stress in tear will be evaluated afte 30 days of treatment with eye drops containing carboxymethylcellulose or xanthan gum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
carboxymethylcellulose
Arm Type
Active Comparator
Arm Description
1 drop in each eye four times a day for 30 days
Arm Title
xanthan gum
Arm Type
Experimental
Arm Description
1 drop in each eye four times a day for 30 days
Intervention Type
Device
Intervention Name(s)
carboxymethylcellulose
Other Intervention Name(s)
THERADROP
Intervention Description
0.25% carboxymethylcellulose preservative free
Intervention Type
Device
Intervention Name(s)
xanthan gum
Other Intervention Name(s)
OXISTOP
Intervention Description
0.2% xanthan gum preservative free
Primary Outcome Measure Information:
Title
Ocular surface disease index (OSDI)
Description
OSDI is a questionnaire including 12 questions to be asked to the patient. From the questionnaire it will be possible to calculate the OSDI score which is a reliable and valid measurement for dry eye severity.
Time Frame
change from baseline OSDI at 30 days
Secondary Outcome Measure Information:
Title
Visual analogue rating scale (VARS)
Description
Global symptoms of dry eye will be graded by patients using a 0-100 mm visual analogue rating scale (0 = no symptoms to 100 = severe symptoms)
Time Frame
change from baseline VARS at 30 days
Title
Fluorescein staining
Description
Eye surface damage (corneal and conjunctival) assessed by fluorescein staining will be graded against standard chart (Oxford system)
Time Frame
change from baseline staining at 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular Surface Disease Index > 12<23 and age >59 yrs
Exclusion Criteria:
contact lens wear and use of other ophthalmic solutions with the exception of artificial tears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Aragona, MD
Organizational Affiliation
University of Messina (ITALY)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Messina
City
Messina
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
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