Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections (DRYEYE-IVT)

Francesco Bandello

Status: Enrolling

Conditions: Dry Eye Syndromes

Treatments: Device: sham (Hydrabak); Device: Thealoz Duo;

Study type: Interventional

Funder types: Other

Identifiers

NCT06317922

DRYEYE-IVT Project

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• patient with naive retinal disease who has already received < 2 anti-VEGF therapy via intravitreal injections in the study eye;
• subjects with autoimmune pathologies involving the ocular surface (e.g.Sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

treatment arm

Experimental group

Description:

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.

Treatment:

Device: Thealoz Duo;

control arm

Placebo Comparator group

Description:

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.

Treatment:

Device: sham (Hydrabak)