Dry Eye
Conditions
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.
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.
Interventions
DEVICEcarboxymethylcellulose
0.25% carboxymethylcellulose preservative free
DEVICExanthan gum
0.2% xanthan gum preservative free
Sponsors
SIFI SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular surface disease index (OSDI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue rating scale (VARS) | 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) |
| Fluorescein staining | 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) |
Countries
Italy
Outcome results
None listed