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?
Opocrin SpA
24 participants
Dec 16, 2009
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
Plain Language Summary
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Interventions
Arabinogalactan monodose ophthalmic 5% (mass/volume percentage) solution, 4 drops per day, over a total of 2 months.
Locations(1)
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ACTRN12612000121864