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

Last updated: March 18, 2024
Sponsor: Francesco Bandello
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eyes

Dry Eye Disease

Treatment

sham (Hydrabak)

Thealoz Duo;

Clinical Study ID

NCT06317922
DRYEYE-IVT Project
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient with retinal disease who required anti-VEGF therapy via intravitrealinjections;
  • patient who has already received at least 2 anti-VEGF therapy via intravitrealinjections in the study eye during the last 6 months before the baseline;
  • Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: sham (Hydrabak)
Phase:
Study Start date:
February 05, 2024
Estimated Completion Date:
May 12, 2025

Connect with a study center

  • IRCCS Ospedale San Raffaele _O.U. Ophthalmology

    Milan, 20123
    Italy

    Active - Recruiting

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