Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Injections

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections. The main questions it aims to answer are: * can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs? * can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision? Each participant will be randomized into each of two arms: 1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day; 2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day; The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement. In any case, the instillation of saline solution should not alter the ocular surface.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patient with retinal disease who required anti-VEGF therapy via intravitreal injections;

• patient who has already received at least 2 anti-VEGF therapy via intravitreal injections in the study eye during the last 6 months before the baseline;

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
RECRUITING
Milan
Contact Information
Primary
Emanuela Aragona, MD-PhD
aragona.emanuela@hsr.it
+390226433512
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2025-05-12
Participants
Target number of participants: 60
Treatments
Experimental: treatment arm
Installation of artificial tears of Thealoz DUO (Investigational medical device containing trehalose 3 g and hyaluronic acid 0.15 g ), 10 ml.~Dosage:1 drop x 4 times/day by 1 week before the Intravitreal injection until 3 months afterward.
Placebo_comparator: control arm
Installation of saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate),10 ml.~Dosage: 1 drop x 4 times/day by 1 week before the Intravitreal injection up to 3 months after it.
Related Therapeutic Areas
Sponsors
Leads: Francesco Bandello

This content was sourced from clinicaltrials.gov