Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Device: carboxymethylcellulose
* Device: xanthan gum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carboxymethylcellulose<br>1 drop in each eye four times a day for 30 days | Device: carboxymethylcellulose<br>* 0.25% carboxymethylcellulose preservative free<br>* Other names: THERADROP;|
| Experimental: xanthan gum<br>1 drop in each eye four times a day for 30 days | Device: xanthan gum<br>* 0.2% xanthan gum preservative free<br>* Other names: OXISTOP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline OSDI at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | change from baseline VARS at 30 days | 
| Fluorescein staining | Eye surface damage (corneal and conjunctival) assessed by fluorescein staining will be graded against standard chart (Oxford system) | change from baseline staining at 30 days |