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

N/ACompletedNCT01959854

SIFI SpA30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye

Interventions

carboxymethylcelluloseDEVICE

0.25% carboxymethylcellulose preservative free

xanthan gumDEVICE

0.2% xanthan gum preservative free

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Messina

Messina, Italy

Outcomes

Primary Outcomes

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.

Time frame: change from baseline OSDI at 30 days

Secondary Outcomes

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)

Time frame: 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)

Time frame: change from baseline staining at 30 days

Data from ClinicalTrials.gov

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