Real-world Study to Assess Adherence to IOP Lowering Therapy in Glaucoma Patients Using CONNECTDROP®

NCT ID: NCT07206628

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-19

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adherence to Glaucoma Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group receiving T9060 CONNECTDROP

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Besomed SRLS

Bari, , Italy

Site Status NOT_YET_RECRUITING

Studio Oculistico D'Azeglio

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Centro Medico Polispecialistico Di Maita

Catania, , Italy

Site Status NOT_YET_RECRUITING

Studio Medico Oculistico Dr.ssa Rosa SCHIAVELLI s.r.l.

Corigliano, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Policlinico S. Martino-IRCCS Clinica Oculistica Università di Genova

Genova, , Italy

Site Status NOT_YET_RECRUITING

Poliambulatorio Chirurgico Modenese Eyecare Clinic

Modena, , Italy

Site Status NOT_YET_RECRUITING

Centro Oculistico Ramovecchi S.r.l.

Morrovalle, , Italy

Site Status 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

Site Status NOT_YET_RECRUITING

Azienda Ospedale-Università Padova Ospedale Sant'Antonio UOC Oculistica

Padua, , Italy

Site Status ACTIVE_NOT_RECRUITING

A.O.U. Pisana UO Oculistica Universitaria

Pisa, , Italy

Site Status NOT_YET_RECRUITING

Ambulatorio Oculistica Ospedale San Carlo di Nancy -GVM-

Roma, , Italy

Site Status NOT_YET_RECRUITING

Fondazione PTV Policlinico Tor Vergata Fondazione PTV Policlinico Tor Vergata UOSD di Oculistica

Roma, , Italy

Site Status 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

Site Status ACTIVE_NOT_RECRUITING

AULSS 4 Veneto Orientale Ospedale di San Donà di Piave Dip. Oculistica

San Donà di Piave, , Italy

Site Status NOT_YET_RECRUITING

AOU Sassari Clinica Oculistica

Sassari, , Italy

Site Status NOT_YET_RECRUITING

Studi Oculistici

Seravezza, , Italy

Site Status RECRUITING

Humanitas Gradenigo U.O. Oculistica

Torino, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Medical Affairs Director

Role: CONTACT

+33 4 73 98 14 36

Facility Contacts

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Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Vincenzo Ramovecchi, Dr

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Marco Brinelli, Dr

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Other Identifiers

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LT9060-002

Identifier Type: -

Identifier Source: org_study_id

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