Performance and Tolerability of the Medical Device LACRIACT (NCT06159569) | Clinical Trial Compass
CompletedNot Applicable
Performance and Tolerability of the Medical Device LACRIACT
Italy20 participantsStarted 2021-09-09
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both genders aged 18-75;
* Patients with clinically diagnosed mild to moderate dry eye syndrome based on Ocular Surface Disesae Index OSDI questionnaire (Italian version) and medical examination;
* Patients with at least two signs and/or symptoms of ocular discomfort;
* Patients with good eyelid mobility;
* Patients must be able to attend the visits scheduled in the study protocol and to follow the instructions given by the Investigator;
* Patients must be able to fill in their diary at home;
* Patients who have given their written informed consent.
Exclusion Criteria:
* Ocular hypertension (\>21 mmHg) or glaucoma with/without alterations of the field of vision;
* Presence of any other eye acute conditions different from eye dry (e.g. acute ulcerative keratitis; acute purulent ophthalmia; ocular tuberculosis; ocular mycosis);
* Eye inflammation or acute eye infection within 3 months before the enrolment;
* Eye surgery within 1 year before enrolment or LASIK at any time before enrolment;
* Known hypersensitivity to any of the components of the devices used in this study;
* Concomitant use of any other eye drop;
* Concomitant use of any local or systemic treatment for dry eye;
* Concomitant use of products with known corneal toxicity and/or steroids, NSAID, or anti-glaucoma drugs;
* Concomitant hormonal therapy;
* Concomitant autoimmune inflammatory diseases or diabetes mellitus;
* Current or past participation in any other clinical trial wh…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.