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Performance and Tolerability of the Medical Device LACRIACT

NCT06159569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-14

No results posted yet for this study

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

Interventions

DEVICE

LACRIACT

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Laboratórios Baldacci S.A

    lead INDUSTRY

Principal Investigators

  • Gennaro Crugliano, MD, Prof · Ospedale San Giovanni di Dio, Crotone (Italy)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2022-12-18
Completion
2023-11-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159569 on ClinicalTrials.gov