At a glance
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Open Not Comparative Clinical Trial on the Performance and Tolerability of the Medical Device LACRIACT, Eye Drops for the Treatment of Dry Eye
In Brief
A clinical study evaluating LACRIACT for Dry Eye and 3 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely. The Investigators will study this in people who have dry eyes, some of whom wear contact lenses, and some who do not. To obtain data from 20 participants, the investigators will first screen 22 patients, as two of them may not meet the requirements. If someone quits the study, the Investigators will not replace them with someone else. A person can partecipate in the study if they meet certain criteria in the study plan, complete the entire treatment, and use eye drops correctly at least 80% of the time. The Investigators running the study might also include up to 10 people who wear soft contact lenses out of the 20 in total. This study will be conducted at a clinic in Italy.
Study Details
Timeline
Interventions
LACRIACT is is a preservative free ophthalmic sterile medical device solution. The solution is packaged in closable vials of inert material that does not affect the contents (clear low-density polyethylene), each vial contains 0.5 ml of solution. Eligible patients will start the treatment. Patients will receive the box of eye drops, and will be instructed on how to self-administer 1 drop in each eye 4 times a day for 30 days starting from the day following the visit.