Adherence to Glaucoma TherapyNCT07206628
Real-world Study to Assess Adherence to IOP Lowering Therapy in Patients With Glaucoma or Ocular Hypertension Using CONNECTDROP®
An observational study of Adherence to Glaucoma Therapy, run by Laboratoires Thea at 15 sites in Italy.
Trial summary
The goal of this real-life, national, multicentre, prospective clinical investigation is to describe the adherence rate over time in patients with glaucoma or OHT already treated with IOP-lowering eye drops using connected device CONNECTDROP® The main questions it aims to answer are: The mean annual adherence rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence to Glaucoma Therapy
- How many people
- 200 participants
- Where
- 15 sitesItaly
- Study dates
- 19 Sep 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma or OHT patients from hospital and/or private practice
Who may be able to join
- Adult patient (≥ 18 years old), man or woman
- Patient with a diagnosis of bilateral open angle glaucoma or OHT
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Italy15 sites, 15 recruiting
- Recruiting
Studio Oculistico D'Azeglio
Bologna, 40100
Gian Luca Laffi
- Recruiting
Centro Medico Polispecialistico Di Maita
Catania
Marco Di Maita
- Recruiting
Studio Medico Oculistico Dr.ssa Rosa SCHIAVELLI s.r.l.
Corigliano
Ester Elmo
- Recruiting
Ospedale Policlinico S. Martino-IRCCS Clinica Oculistica Università di Genova
Genova, 16132
Michele Iester
- Recruiting
Centro Corporis Lab
Lecce, 73100
Gianluca Besozzi
- Recruiting
Studi Oculistici - Dott. Andrea Bedei
Lucca, 55047
Andrea Bedei
- Recruiting
Poliambulatorio Chirurgico Modenese Eyecare Clinic
Modena
Enrico Martini
- Recruiting
Centro Oculistico Ramovecchi S.r.l.
Morrovalle, 62010
Vincenzo Ramovecchi
- Recruiting
Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontostomatologiche, Università degli studi di Napoli Federico II
Naples
Ciro Costagliola
- Recruiting
UOSD di Oculistica, Fondazione PTV Policlinico Tor Vergata
Roma, 00133
Carlo Nucci
- Not yet recruiting
Ambulatorio Oculistica Ospedale San Carlo di Nancy -GVM-
Roma, 00165
Marco Brinelli
- Recruiting
IRCCS Fondazione G.B. Bietti
Roma, 00184
Francesco Oddone
- Recruiting
Ospedale San Donà Piave, Aussl 4 Veneto Orientale, UOC Oculistica
San Donà di Piave
Francesco Giuseppe Stefanon
- Recruiting
AOU Sassari Clinica Oculistica
Sassari, 07100
Matteo Sacchi
- Recruiting
Humanitas Gradenigo U.O. Oculistica
Torino, 10153
Teresa Rolle
About this study
Official title: Real-world Study to Assess Adherence to IOP Lowering Therapy in Patients With Glaucoma or Ocular Hypertension Using CONNECTDROP®: the GRANITE Study (Glaucoma tReatment AdhereNce wIth connecTed dEvice in Italy)
The goal of this real-life, national, multicentre, prospective clinical investigation is to describe the adherence rate over time in patients with glaucoma or OHT 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.
- Conditions
- Adherence to Glaucoma Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving T9060 CONNECTDROP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate over time in patients with glaucoma or OHT 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).
Measured: From enrollment to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start19 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Glaucoma TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206628
- Sponsor's protocol ID
- LT9060-002
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study to Assess Adherence to IOP Lowering Therapy in Patients With Glaucoma or Ocular Hypertension Using CONNECTDROP®: the GRANITE Study (Glaucoma tReatment AdhereNce wIth connecTed dEvice in Italy)
- ClinicalTrials.gov ID
- NCT07206628
- Acronym / sponsor ID
- LT9060-002
- Conditions
- Adherence to Glaucoma Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this real-life, national, multicentre, prospective clinical investigation is to describe the adherence rate over time in patients with glaucoma or OHT 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group receiving T9060 CONNECTDROP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma or OHT patients from hospital and/or private practice
Key inclusion criteria (5 listed)
- Adult patient (≥ 18 years old), man or woman
- Patient with a diagnosis of bilateral open angle glaucoma or OHT
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence rate over time in patients with glaucoma or OHT already treated with IOP-lowering eye drops in EASYGRIP® bottle clipped with CONNECTDROP®
Time frame: From enrollment to the end of the study at 12 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence to Glaucoma Therapy, run by Laboratoires Thea at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Operation Manager (+33 4 73 98 14 36, Fabienne.HESKIA@theapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate over time in patients with glaucoma or OHT already treated with IOP-lowering eye drops in EASYGRIP® bottle clipped with CONNECTDROP® (time frame: From enrollment to the end of the study at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.