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OpenTrials
Completed

NCT Number: NCT01959854

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboxymethylcellulose

Device

0.25% carboxymethylcellulose preservative free

Other names: THERADROP

xanthan gum

Device

0.2% xanthan gum preservative free

Other names: OXISTOP

Primary outcomes

  1. Ocular surface disease index (OSDI)

    Time frame: 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 outcomes

  1. Visual analogue rating scale (VARS)

    Time frame: 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)

  2. Fluorescein staining

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Registry information

Official study title

Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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