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

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ClinicalTrials.gov Identifier: NCT01959854
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Device: carboxymethylcellulose Device: xanthan gum Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: carboxymethylcellulose
1 drop in each eye four times a day for 30 days
Device: carboxymethylcellulose
0.25% carboxymethylcellulose preservative free
Other Name: THERADROP

Experimental: xanthan gum
1 drop in each eye four times a day for 30 days
Device: xanthan gum
0.2% xanthan gum preservative free
Other Name: OXISTOP




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959854


Locations
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Italy
University of Messina
Messina, Italy
Sponsors and Collaborators
SIFI SpA
Investigators
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Principal Investigator: Pasquale Aragona, MD University of Messina (ITALY)

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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT01959854     History of Changes
Other Study ID Numbers: XNTME2013
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents