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Dry Eye SyndromesDRYEYE-IVTNCT06317922

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

A study testing Thealoz Duo; in people with Dry Eye Syndromes, run by Francesco Bandello at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Thealoz Duo;
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
5 Feb 2024to 12 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Emanuela Aragona, MD-PhD contact

+390226433512

aragona.emanuela@hsr.it

Italy1 site, 1 recruiting

  • IRCCS Ospedale San Raffaele _O.U. Ophthalmology

    Milan, 20123

    Giulia Basile, MPharm, +39 0226433545, basile.giulia@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: 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:

Read more
  • 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.

Being tested
Thealoz Duo;, sham (Hydrabak)
Keywords
ocular surface discomfort
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thealoz Duo;Device

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

    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.

  • sham (Hydrabak)Device

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

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

Study groups in NCT06317922
Study groupRoleWhat they receive
treatment armExperimentalInstallation 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.
Receives: Device: Thealoz Duo;
control armPlacebo comparatorInstallation 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.
Receives: Device: sham (Hydrabak)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Administration of Ocular Surface Disease Index (OSDI) to the patient

    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.

    Measured: 3 months and 1 week

Secondary outcomes (7)

  1. administration of Visual Analog Scale for Pain to the patient

    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').

    Measured: 3 months and 1 week

  2. evaluation of matrix metalloproteinase 9 gene expression

    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.

    Measured: 3 months and 1 week

  3. TearLab Osmolarity

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

    -TearLab Osmolarity.

    Measured: 3 months and 1 week

  4. Schirmer's test

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

    -Schirmer's test.

    Measured: 3 months and 1 week

  5. tear film Break Up Time (tBUT)

    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).

    Measured: 3 months and 1 week

  6. conjunctival hyperemia according to Efron grading scale

    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).

    Measured: 3 months and 1 week

  7. fluorescein staining

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

    -fluorescein staining.

    Measured: 3 months and 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start5 Feb 2024
  3. Primary completion12 May 2025 (estimated)
  4. Study completion12 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06317922
Sponsor's protocol ID
DRYEYE-IVT Project
Acronym
DRYEYE-IVT
Status last verified
Mar 2024
First submitted
12 Mar 2024
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cejka C, Kubinova S, Cejkova J. Trehalose in ophthalmology. Histol Histopathol. 2019 Jun;34(6):611-618. doi: 10.14670/HH-18-082. Epub 2019 Jan 9.

    PubMed 30623968

  • Chiambaretta F, Doan S, Labetoulle M, Rocher N, Fekih LE, Messaoud R, Khairallah M, Baudouin C; HA-trehalose Study Group. A randomized, controlled study of the efficacy and safety of a new eyedrop formulation for moderate to severe dry eye syndrome. Eur J Ophthalmol. 2017 Jan 19;27(1):1-9. doi: 10.5301/ejo.5000836. Epub 2016 Jul 20.

    PubMed 27445067

  • Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and proposed management strategies. Clin Ophthalmol. 2017 Aug 16;11:1491-1497. doi: 10.2147/OPTH.S136500. eCollection 2017.

    PubMed 28860698

  • Dohlman TH, Lertsuwanroj B, D'Amico DJ, Ciralsky JB, Kiss S. Evaluation of signs and symptoms of ocular surface disease after intravitreal injection. Acta Ophthalmol. 2019 Dec;97(8):e1154-e1156. doi: 10.1111/aos.14146. Epub 2019 Jun 25. No abstract available.

    PubMed 31237739

  • Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul Toxicol. 2017 Dec;36(4):343-346. doi: 10.1080/15569527.2017.1291665. Epub 2017 Feb 28.

    PubMed 28166657

Questions about this trial

What is this clinical trial studying?

A study testing Thealoz Duo; in people with Dry Eye Syndromes, run by Francesco Bandello at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emanuela Aragona, MD-PhD (+390226433512, aragona.emanuela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Administration of Ocular Surface Disease Index (OSDI) to the patient (time frame: 3 months and 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06317922, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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