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

Dry Eye Syndromes Clinical Trial

— DRYEYE-IVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317922
• Other study ID #: DRYEYE-IVT Project
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: May 12, 2025

Study information

• Verified date: March 2024
• Source: IRCCS Ospedale San Raffaele
• Contact: Emanuela Aragona, MD-PhD
• Phone: +390226433512
• Email: aragona.emanuela[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 12, 2025
• Est. primary completion date: May 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele _O.U. Ophthalmology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Francesco Bandello

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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 — View Citation

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 availa — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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').	3 months and 1 week
Secondary	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.	3 months and 1 week
Secondary	TearLab Osmolarity	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
Secondary	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.	3 months and 1 week
Secondary	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).	3 months and 1 week
Secondary	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).	3 months and 1 week
Secondary	fluorescein staining	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