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

Dry Eye Clinical Trial

Official title:

Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959854
• Other study ID #: XNTME2013
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 15, 2014
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• carboxymethylcellulose
0.25% carboxymethylcellulose preservative free
• xanthan gum
0.2% xanthan gum preservative free

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
SIFI SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No