Dry Eye Clinical Trial
Official title:
Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye
Verified date | October 2014 |
Source | SIFI SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Messina | Messina |
Lead Sponsor | Collaborator |
---|---|
SIFI SpA |
Italy,
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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