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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Device: carboxymethylcellulose; Device: xanthan gum

• Registration Number: NCT01959854
• Lead Sponsor: SIFI SpA

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carboxymethylcellulose	carboxymethylcellulose	1 drop in each eye four times a day for 30 days
xanthan gum	xanthan gum	1 drop in each eye four times a day for 30 days

Primary Outcome Measures

Name	Time	Method
Ocular surface disease index (OSDI)	change from baseline OSDI at 30 days	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

Name	Time	Method
Visual analogue rating scale (VARS)	change from baseline VARS at 30 days	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	change from baseline staining at 30 days	Eye surface damage (corneal and conjunctival) assessed by fluorescein staining will be graded against standard chart (Oxford system)

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy