Evaluating a treatment for dry eye in patients receiving eye injections
Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Injections
This study is testing if using Thealoz Duo, an artificial tear solution, can help people with retinal diseases feel more comfortable and improve their vision after getting eye injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06317922 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the effectiveness of Thealoz Duo, an artificial tear solution, in reducing ocular discomfort and side effects in patients who have received intravitreal anti-VEGF injections. Participants will be randomized into two groups: one receiving Thealoz Duo and the other receiving a saline solution. The study will evaluate whether pre- and post-injection use of Thealoz Duo can prevent ocular surface changes and improve quality of life and vision. The study is monocentric and single-masked, focusing on patients with retinal diseases requiring anti-VEGF therapy.
Who should consider this trial
Good fit: Ideal candidates are patients with retinal disease who have received at least two anti-VEGF injections in the study eye within the last six months.
Not a fit: Patients with autoimmune ocular surface diseases or those who have not received sufficient anti-VEGF therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate dry eye symptoms and improve the quality of life for patients undergoing intravitreal injections.
How similar studies have performed: While similar approaches have been explored, this specific evaluation of Thealoz Duo in the context of anti-VEGF therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele _O.U. Ophthalmology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Bandello, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Emanuela Aragona, MD-PhD
- Email: aragona.emanuela@hsr.it
- Phone: +390226433512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.