Real-world Study to Assess Adherence to IOP Lowering Ther... | NCT07206628

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

NCT07206628

Sponsor

Laboratoires Thea

Status

Recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Adherence to Glaucoma Therapy

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Sep 26, 2025

First Submission Date that Met QC Criteria

Sep 26, 2025

First Posted Date

Oct 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Group receiving T9060 CONNECTDROP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Glaucoma patients from hospital and/or private practice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical Affairs Director	Contact	+33 4 73 98 14 36		Florence.NOIRT@theapharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Besomed SRLS	Not yet recruiting	Bari			Italy