Status:
COMPLETED
Performance and Tolerability of the Medical Device LACRIACT
Lead Sponsor:
Laboratórios Baldacci S.A
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Dry Eye
Contact Lens Acute Red Eye
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 o...
Detailed Description
Dry eye disease is defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to th...
Eligibility Criteria
Inclusion
- 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
- 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 which has ended less than a month before the enrolment;
- Use of hard contact lenses;
- Patients unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06159569
Start Date
September 9 2021
End Date
November 28 2023
Last Update
December 14 2023
Active Locations (1)
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1
USOD Oculistica, Presidio Ospedaliero di Crotone, Ospedale San Giovanni di Dio
Crotone, Italy, 88900