In patients with moderate dry eye syndrome is a three months treatment with with arabinogalactan monodose ophthalmic formulation 5% as safe and effective as hyaluronic acid 0.2% for the control of subjective and objective symptoms of dry eye?

Opocrin SpA0 sites24 target enrollmentJanuary 25, 2012

Overview

No summary available.

Registry

who.int

Start Date

January 25, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Written informed consent.
•2\. Male and female subjects ages \>18 years.
•3\. Diagnosis of moderate dry\-eye syndrome confirmed at least two months prior screening visit.
•4\. At the screening visit, all the following conditions must be present: a) sum of scores for all answered questions of the OSDI questionnaire between 10 and 25 (mild to moderate); b) BUT \< 10 seconds or Schirmer\-1 test \< 5\.5 mm after 5 minutes; c) at least one ocular surface area having score \> 2 (corneal or conjunctival damage grading from 0 to 3\) when intravital stained.

•1\. Difficulty in understanding properly the questionnaire on dry eye.
•2\. Pregnant or breastfeeding women.
•3\. Eye surgery performed in the previous three months.
•4\. Treatment in the previous three months of dry eye with any ophthalmic formulation of hyaluronic acid.
•5\. Use of any other eye drop treatment, other than specified study product, for duration of study.
•6\. Contact lenses wearers.
•7\. Severe dry\-eye sufferers defined as patients with a BUT \<1\.5 seconds.
•8\. Presence or onset of eye infections or of other acute pathologies that might resolve or evolve throughout the study regardless of the study treatment.
•9\. Onset during the study of eye pathologies capable of causing alterations of tear secretion and in the ocular surface.
•10\. Participation in a clinical trial within 3 months of the beginning of the study.