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NCT06317922: DRYEYE-IVT
Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections
NA trial testing Thealoz Duo; in Dry Eye Syndromes in 60 participants. Status unknown.
12 May 2025
Quick facts
| Lead sponsor | Francesco Bandello |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 5 February 2024 |
| Primary completion | 12 May 2025 |
| Estimated completion | 12 May 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Thealoz Duo;
- sham (Hydrabak)
Conditions studied
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
Francesco Bandello
Who can join
18 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06317922
- Europe PMC full search
- ASCO Meeting Library
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Currently open trials in the same condition.
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- NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
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Other Francesco Bandello trials
Trials by the same sponsor.
- NCT06582511 — Evaluating Metabolic Changes Induced by PhotoBioModulation Through Spectrally Resolved Autofluorescence in Dry Age-Relat · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06317922 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Francesco Bandello
- Last refreshed: 20 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06317922.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing