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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01959854
Other study ID # XNTME2013
Secondary ID
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


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
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