Performance and Tolerability of the Medical Device LACRIACT

NCT06159569 | Completed

• 1 other identifier: LACRIACT 1/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dry Eye; Contact Lens Acute Red Eye; Photophobia; Discomfort

Keywords

LACRIACT; Contact lens; Photophobia; Stickiness of eyelashes; Italy

Outcome Measures

Primary Outcomes (2)

• Schirmer Test

  The test will be performed as follows: A standardized tear testing strips is placed between the eyeball and the lateral margin of the lower lid, the conjunctival sac of the patient, and the advancement of a tear film over a period of 5 minutes is noted. The Investigator traces the tear edge with a pen, measuring the shortest and longest parts. More than 10 mm of moisture on the filter paper after 5 minutes is a sign of normal tear production. Both eyes are tested at the same time and both eyes normally release the same amount of tears. The values obtained after 30 days of treatment will be compared with the baseline (day 0) values.

  30 days

• Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE) and Device Deficiency (DD)

  The occurrence of SADE, SAE, ADE, AE and DD will be monitored to assess the overall safety of the device

  30 days

Secondary Outcomes (21)

• Tear breakup time (TBUT))

  30 days

• Foreign body sensation

  30 days

• Redness

  30 days

• Lachrymation

  30 days

• Photophobia

  30 days

Study Arms (1)

Population treated with LACRIACT

EXPERIMENTAL

20 patients affected by dry eye who met the inclusion and exclusion criteria.. It is optional for the Investigator to recruit a sub-group of patients (maximum number 10 of 20 recruited patients) with regular soft contact lens that will be analysed separately.

Device: LACRIACT

Interventions

LACRIACT DEVICE

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.

Population treated with LACRIACT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratórios Baldacci S.A: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

USOD Oculistica, Presidio Ospedaliero di Crotone, Ospedale San Giovanni di Dio

Crotone, 88900, Italy

Location

Related Publications (4)

• The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.

  PMID: 17508116 BACKGROUND

• Ang BCH, Sng JJ, Wang PXH, Htoon HM, Tong LHT. Sodium Hyaluronate in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-Analysis. Sci Rep. 2017 Aug 21;7(1):9013. doi: 10.1038/s41598-017-08534-5.

  PMID: 28827614 BACKGROUND

• Fraser JR, Laurent TC, Laurent UB. Hyaluronan: its nature, distribution, functions and turnover. J Intern Med. 1997 Jul;242(1):27-33. doi: 10.1046/j.1365-2796.1997.00170.x.

  PMID: 9260563 BACKGROUND

• Tampucci S, Monti D, Burgalassi S, Terreni E, Zucchetti E, Baldacci F, Chetoni P. Effect of 5-Oxo-2-Pyrrolidinecarboxylic Acid (PCA) as a New Topically Applied Agent for Dry Eye Syndrome Treatment. Pharmaceutics. 2018 Aug 25;10(3):137. doi: 10.3390/pharmaceutics10030137.

  PMID: 30149648 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Photophobia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gennaro Crugliano, MD, Prof

  Ospedale San Giovanni di Dio, Crotone (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, non comparative study with a medical device

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: September 9, 2021
• Primary Completion: December 18, 2022
• Study Completion: November 28, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)