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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carboxymethylcellulose | Active Comparator | 1 drop in each eye four times a day for 30 days |
|
| xanthan gum | Experimental | 1 drop in each eye four times a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboxymethylcellulose | Device | 0.25% carboxymethylcellulose preservative free |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fluorescein staining |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale Aragona, MD | University of Messina (ITALY) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Messina | Messina | Italy |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| xanthan gum | Device | 0.2% xanthan gum preservative free |
|
|
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 |