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

NCT06317922 | Recruiting

• 1 other identifier: DRYEYE-IVT Project
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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:
• TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;
• CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;

Conditions

Dry Eye Syndromes

Keywords

ocular surface discomfort

Outcome Measures

Primary Outcomes (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.

  3 months and 1 week

Secondary Outcomes (7)

• administration of Visual Analog Scale for Pain to the patient

  3 months and 1 week

• evaluation of matrix metalloproteinase 9 gene expression

  3 months and 1 week

• TearLab Osmolarity

  3 months and 1 week

• Schirmer's test

  3 months and 1 week

• tear film Break Up Time (tBUT)

  3 months and 1 week

Study Arms (2)

treatment arm

EXPERIMENTAL

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;

control arm

PLACEBO COMPARATOR

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)

Interventions

Thealoz Duo; 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.

Also known as: manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd.

treatment arm

sham (Hydrabak) DEVICE

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

Also known as: manufacturer: Laboratoires Théa; distributor: THEA Pharmaceuticals Ltd.

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francesco Bandello: lead

Study Sites (1)

IRCCS Ospedale San Raffaele _O.U. Ophthalmology

Milan, 20123, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 30623968 RESULT

• 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.

  PMID: 27445067 RESULT

• 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.

  PMID: 28860698 RESULT

• 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.

  PMID: 31237739 RESULT

• 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.

  PMID: 28166657 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Francesco Bandello, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuela Aragona, MD-PhD

CONTACT

+390226433512; aragona.emanuela@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor and Chairman of Department of Ophthalmology

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

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: February 5, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)