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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaboratoires Thea

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Glaucoma or OHT patients from hospital and/or private practice

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Group receiving T9060 CONNECTDROP

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of the study at 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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