RANDOMIZED CONTROLLED CLINICAL STUDY ON THE EFFICACY AND TOLERABILITY OF 0.4% HYALURONIC ACID HYPOTONIC EYE DROPS (IALUREX) VS. HYDROXYPROPYL-GUAR EYE DROPS (SYSTANE) IN THE TREATMENT OF DRY EYE SYNDROME - ND

• Conditions: Dry eye syndrome; MedDRA version: 9.1Level: LLTClassification code 10023350Term: Keratoconjunctivitis sicca

• Registration Number: EUCTR2007-005882-37-IT
• Lead Sponsor: BAUSCH&LOMB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Legally adult outpatients having given their written informed consent with : 1. Dry eye syndrome (either hyposecretive or hyperevaporative type) since at least two months. 2. Schirmer l test≤10 mm/5 min. 3. Positivity to vital corneal staining≥3/15 (NEI scheme). 4. Symptomatology of dry eye with at least two positive symptoms (VAS>60) in the preceding 72 hours, out of five: -burning/stinging sensation, -ocular discomfort while blinking -foreign body sensation -sensation of ocular fatigue/heaviness of the lid -willingness to keep eyes closed. 5. Willingness to participate in the study while following the indications
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age <18 years.
2.Pregnant or lactating women.
3.Women of childbearing potential who are not using adequate contraception methods.
4.Ocular surgery within the last three months.
5.Presence or onset of eye infections or of other acute pathologies which could be resolved or modified during the course of the study independently from the treatment with study drugs.
6.Presence or onset of glaucoma.
7.Using any topical ophthalmic medication with the exception of tear substitutes and/or eye cleaning solutions for the treatment of dry eye.
8.Patients being treated with topical ocular, cyclosporine, steroidal or non steroidal, anti-inflammatory medications within the last month.
9.Occlusion therapy with lachrymal or punctum plugs within the last 2 months.
10.Change in systemic treatment within the last 2 months.
11.Contact lens wearers.
12.Patients who have participated in any clinical investigation within the last 30 days or are currently participating in a clinical study.
13.Patients who are unlikely to comply with the requirements of the study protocol or who are at risk of moving or being lost to follow up.
14.Expected change in treatment of concomitant disease.
15.Patients with a history of recurrent ocular herpes and/or recurrent uveitis.
16.Inadequate lid closure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of Ialurex vs. Systane Eye Drops on the basis of the improvement of corneal fluorescein staining;Secondary Objective: a) improvement of tear film stability b) improvement of ocular symptomatology;Primary end point(s): Primary efficacy variable of the study is: Efficacy of Ialurex vs. Systane Eye Drops on the basis of: -Improvement of fluorescein corneal staining