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

NCT06317922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndromes

Interventions

DEVICE

Thealoz Duo;

THEALOZ DUO is a solution containing trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid, and water for injections; Hydraback is a solution containing a sodium chloride 0.9 %, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, water for preparations for injection.

DEVICE

sham (Hydrabak)

Hydrabak is an ophthalmic solution containing: sodium chloride 0.9%, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, and water for injectable preparations

Sponsors & Collaborators

  • Francesco Bandello

    lead OTHER

Principal Investigators

  • Francesco Bandello, MD · IRCCS Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-05-12
Completion
2025-05-12

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 NCT06317922 on ClinicalTrials.gov