NCT07206628

Brief Summary

The goal of this real-life, national, multicentre, prospective clinical investigation is to describe the adherence rate over time in patients with glaucoma already treated with IOP-lowering eye drops using connected device CONNECTDROP® The main questions it aims to answer are:

  • The mean annual adherence rate, defined as the percentage of the prescribed doses taken by the patient
  • The adherence profile of each patient
  • The association between the adherence profile, the objective adherence data and the clinical data. Participants will use the connected device CONNECTDROP® associated with the smartphone application on a daily basis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Sep 2025

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2025Mar 2027

Study Start

First participant enrolled

September 19, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

September 26, 2025

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence rate over time in patients with glaucoma already treated with IOP-lowering eye drops in EASYGRIP® bottle clipped with CONNECTDROP®

    Assessment of the mean annual adherence rate, defined as the percentage of the prescribed doses actually taken by the patient (i.e. at least 2 instillations per day).

    From enrollment to the end of the study at 12 months

Study Arms (1)

Group receiving T9060 CONNECTDROP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients from hospital and/or private practice

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

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, 62010, 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

Napoli, Italy

NOT YET RECRUITING

Azienda Ospedale-Università Padova Ospedale Sant'Antonio UOC Oculistica

Padua, 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, 00165, 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

Central Study Contacts

Medical Affairs Director

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

September 19, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations