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

NCT ID: NCT01959854

Last Updated: 2014-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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carboxymethylcellulose

1 drop in each eye four times a day for 30 days

Group Type ACTIVE_COMPARATOR

carboxymethylcellulose

Intervention Type DEVICE

0.25% carboxymethylcellulose preservative free

xanthan gum

1 drop in each eye four times a day for 30 days

Group Type EXPERIMENTAL

xanthan gum

Intervention Type DEVICE

0.2% xanthan gum preservative free

Interventions

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carboxymethylcellulose

0.25% carboxymethylcellulose preservative free

Intervention Type DEVICE

xanthan gum

0.2% xanthan gum preservative free

Intervention Type DEVICE

Other Intervention Names

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THERADROP OXISTOP

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SIFI SpA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pasquale Aragona, MD

Role: PRINCIPAL_INVESTIGATOR

University of Messina (ITALY)

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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XNTME2013

Identifier Type: -

Identifier Source: org_study_id

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