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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2025-05-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

There are two teams:

1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks:

* dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate);
* accountability of Investigational medical device and saline solution;
* verify the compliance and therapeutic adherence of the patient;
* discussion with the patient regarding the respect of the masked condition of the study;
2. UNMASKED TEAMS:

* informed consent process;
* to perform the follow-up visit and assessments provided to test the ocular surface.

Study Groups

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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.

Group Type EXPERIMENTAL

Thealoz Duo;

Intervention Type DEVICE

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.

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.

Group Type PLACEBO_COMPARATOR

sham (Hydrabak)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd. manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No