CompletedPhase 2ACTRN12612000121864

A pilot open label clinical trial on the comparison of three months treatment with arabinogalactan monodose ophthalmic formulation 5% or hyaluronic acid 0.2% (Hyalistil (Registered Trademark) monodose 0.2%) in patients with moderate dry eye syndrome.

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?


Sponsor

Opocrin SpA

Enrollment

24 participants

Start Date

Dec 16, 2009

Study Type

Interventional

Conditions

Summary

Controlled open label randomized monocenter clinical study designed to evaluate, in patients suffering from moderate dry eye syndrome, subjective and objective safety and efficacy parameters during and after three months of treatment (4 drops per day) with arabinogalactan 5% w/v solution or hyaluronic acid 0.2% w/v solution . Hyaluronic acid is a widely used tear substitute prescribed for the same indication. Arabinogalactan is a new class 1 medical device according to the European rules. This study is the first clinical trial using arabinogalactan ophthalmic formulation 5% as test product.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot trial compares arabinogalactan eye drops (5%) with hyaluronic acid eye drops (0.2%) for treating moderate dry eye syndrome over three months. Adults aged 18 and over who have had a diagnosis of moderate dry eye for at least two months may be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arabinogalactan monodose ophthalmic 5% (mass/volume percentage) solution, 4 drops per day, over a total of 2 months.

Arabinogalactan monodose ophthalmic 5% (mass/volume percentage) solution, 4 drops per day, over a total of 2 months.


Locations(1)

Italy

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ACTRN12612000121864