Comparing T2769 and Vismed® Multi for treating moderate to severe dry eye syndrome
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
This study is testing if a new treatment called T2769 works as well as Vismed® Multi for people with moderate to severe dry eye syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires Thea Industry-sponsored |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05965778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to demonstrate that T2769 is as effective as Vismed® Multi in treating moderate to severe dry eye syndrome. Participants will receive either T2769 or Vismed® Multi for 35 days, with the primary outcome measured by total ocular surface staining using the Oxford score. The study will also evaluate the safety of both treatments. Eligible participants must have a history of dry eye syndrome and meet specific ocular discomfort criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe dry eye syndrome requiring artificial tears.
Not a fit: Patients with severe visual impairment or specific ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from moderate to severe dry eye syndrome.
How similar studies have performed: Other studies have shown success in comparing treatments for dry eye syndrome, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent signed and dated (obtained prior to initiating any procedures). * Patient aged ≥18 years old. * Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit. * Surface Disease Index (OSDI) Score ≥ 23. * Ocular discomfort evaluated by VAS ≥ 40 mm. Exclusion Criteria: * Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study). * Severe blepharitis according to the judgment of the investigator * Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Where this trial is running
Clermont-Ferrand
- Gabriel-Montpied University Hospital — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Frédéric CHIAMBARETTA, Prof. — Individual Practice for Specialized Ophthalmology Care
- Study coordinator: Corentin LE CAMUS
- Email: Corentin.LECAMUS@theapharma.com
- Phone: +33473981436
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.