Tracking eye-drop use with CONNECTDROP® for people with glaucoma
Real-world Study to Assess Adherence to IOP Lowering Therapy in Glaucoma Patients Using CONNECTDROP®: the GRANITE Study (Glaucoma tReatment AdhereNce wIth connecTed dEvice in Italy)
This project will try using the CONNECTDROP® smart device and smartphone app to track daily eye-drop use in adults with open-angle glaucoma to measure how well they follow their prescribed treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires Thea Industry-sponsored |
| Locations | 17 sites (Bari and 16 other locations) |
| Trial ID | NCT07206628 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter, prospective observational study in which adults with bilateral open-angle glaucoma who are on a single IOP‑lowering eye drop in an EASYGRIP® bottle will use the CONNECTDROP® device and companion smartphone app daily. The main outcome is the mean annual adherence rate (percentage of prescribed doses taken) and the individual adherence profiles over time. The study will link objective adherence data from the device with clinical information to explore associations between adherence and clinical status. Pregnant or lactating people and those receiving other chronic ocular instillations are excluded from participation.
Who should consider this trial
Good fit: Adults (≥18 years) with bilateral open-angle glaucoma who have been using a single IOP-lowering eye drop in an EASYGRIP® bottle for at least six weeks and who are willing to use the CONNECTDROP® device and smartphone app are ideal candidates.
Not a fit: Patients who are pregnant or lactating, on other chronic ocular treatments, unable or unwilling to use a smartphone-connected device, or unable to attend one of the study sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could help clinicians identify patients who miss doses and enable targeted support to improve treatment adherence and potentially better IOP control.
How similar studies have performed: Similar connected-device and smartphone approaches have shown feasibility and some improvements in adherence in glaucoma and other chronic conditions, but results have been variable and not uniformly conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥ 18 years old), man or woman * Patient with a diagnosis of bilateral open angle glaucoma * Patients being prescribed with glaucoma eye drops in EASYGRIP® bottle for at least 6 weeks in monotherapy. * Patient willing to participate in the study * Patient who consents for data collection in the frame of the study Exclusion Criteria: * Pregnant and/or lactating woman * Patient receiving another ocular treatment for a chronic condition (i.e. regular instillations for several months) * Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
Where this trial is running
Bari and 16 other locations
- Besomed SRLS — Bari, Italy (Not_yet_recruiting)
- Studio Oculistico D'Azeglio — Bologna, Italy (Not_yet_recruiting)
- Centro Medico Polispecialistico Di Maita — Catania, Italy (Not_yet_recruiting)
- Studio Medico Oculistico Dr.ssa Rosa SCHIAVELLI s.r.l. — Corigliano, Italy (Not_yet_recruiting)
- Ospedale Policlinico S. Martino-IRCCS Clinica Oculistica Università di Genova — Genova, Italy (Not_yet_recruiting)
- Poliambulatorio Chirurgico Modenese Eyecare Clinic — Modena, Italy (Not_yet_recruiting)
- Centro Oculistico Ramovecchi S.r.l. — Morrovalle, Italy (Not_yet_recruiting)
- AOU Federico II di Napoli Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontostomatologiche Università degli studi di Napoli Federico II U.O.C. di Oftalmologia — Naples, Italy (Not_yet_recruiting)
- Azienda Ospedale-Università Padova Ospedale Sant'Antonio UOC Oculistica — Padova, Italy (Active_not_recruiting)
- A.O.U. Pisana UO Oculistica Universitaria — Pisa, Italy (Not_yet_recruiting)
- Ambulatorio Oculistica Ospedale San Carlo di Nancy -GVM- — Roma, Italy (Not_yet_recruiting)
- Fondazione PTV Policlinico Tor Vergata Fondazione PTV Policlinico Tor Vergata UOSD di Oculistica — Roma, Italy (Not_yet_recruiting)
- IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS Presidio Ospedaliero Britannico Unità di Ricerca "Glaucoma — Roma, Italy (Active_not_recruiting)
- AULSS 4 Veneto Orientale Ospedale di San Donà di Piave Dip. Oculistica — San Donà di Piave, Italy (Not_yet_recruiting)
- AOU Sassari Clinica Oculistica — Sassari, Italy (Not_yet_recruiting)
- Studi Oculistici — Seravezza, Italy (Recruiting)
- Humanitas Gradenigo U.O. Oculistica — Torino, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Medical Affairs Director
- Email: Florence.NOIRT@theapharma.com
- Phone: +33 4 73 98 14 36
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.