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

March 18, 2024 updated by: Francesco Bandello

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20123
        • Recruiting
        • IRCCS Ospedale San Raffaele _O.U. Ophthalmology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd.
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.
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
Other Names:
  • manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of Ocular Surface Disease Index (OSDI) to the patient
Time Frame: 3 months and 1 week
The primary outcome is to evaluate the improvement of the dry-eye signs and changes in the ocular surface in patients who have received the intravitreal injections through the administration of Ocular Surface Disease Index (OSDI) at baseline, at month 1 and month 3 after the intravitreal injections.
3 months and 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of matrix metalloproteinase 9 gene expression
Time Frame: 3 months and 1 week

The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:

-evaluation of matrix metalloproteinase 9 gene expression.
3 months and 1 week
TearLab Osmolarity
Time Frame: 3 months and 1 week

The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:

-TearLab Osmolarity.
3 months and 1 week
Schirmer's test
Time Frame: 3 months and 1 week

The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:

-Schirmer's test.
3 months and 1 week
tear film Break Up Time (tBUT)
Time Frame: 3 months and 1 week

The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:

-tear film Break Up Time (tBUT).
3 months and 1 week
fluorescein staining
Time Frame: 3 months and 1 week

The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:

-fluorescein staining.
3 months and 1 week
administration of Visual Analog Scale for Pain to the patient
Time Frame: 3 months and 1 week
The Visual Analogue Scale measures pain intensity and consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be').
3 months and 1 week
conjunctival hyperemia according to Efron grading scale
Time Frame: 3 months and 1 week
The Efron grading scale describe the severity of contact lens complications (grade 0: normal; grade 1: trace; grade 2: mild; grade 3: moderate; grade 4: severe).
3 months and 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francesco Bandello

Investigators

  • Principal Investigator: Francesco Bandello, MD, Irccs Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

May 12, 2025

Study Completion (Estimated)

May 12, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRYEYE-IVT Project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on Thealoz Duo;

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe