Assessment of the Impact of an add-on and Its Smartphone... | NCT04552964

Studies
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

NCT04552964

Sponsor

Laboratoires Thea

Status

Completed

Last Update Posted

Jul 14, 2021Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Single arm

Countries

France

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2020Actual

Primary Completion Date

Apr 27, 2021Actual

Completion Date

Apr 27, 2021Actual

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Sep 16, 2020

First Posted Date

Sep 17, 2020Actual

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

Jul 13, 2021

Last Update Posted Date

Jul 14, 2021Actual

Description Module

Brief Summary

Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.

One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Other	This will be a single centre, single-arm, prospective pilot study.	Other: Single arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single arm	Other	Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire

Measure	Description	Time Frame
Global patient satisfaction	Global patient satisfaction (Patient satisfaction questionnaire)	Week 9

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient > 18 years old, both genders
Diagnosed with glaucoma, with controlled IOP (<18mmHg)
Currently receiving a topical glaucoma treatment
Receiving a multitherapy a fixed combination of dorzolamide-timolol, preservative-free.
Patient willing to participate in the study.
Patient familiar with a smartphone and its applications

Exclusion Criteria:

Patient with any eye condition in addition to glaucoma requiring expected additional treatment
Patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection.
Patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months
Patient with best-correct visual acuity <20/70 in the better seeing eye
Patient whose drop administration is performed by someone else
Alcohol addiction and/or heavy smoker, according to the investigator's judgement.
Patient inability to understand the study procedures or to give informed consent.
Non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance).
Participation in this study at the same time as in another clinical study.
Patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study sites or of the sponsor's company.
Patient not covered by the government health care scheme of the country in which he/she is living (if applicable).
Women of childbearing potential, pregnant or breastfeeding: Childbearing potential is defined as a woman who is not using a reliable method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, patch) or is not surgically sterilized.

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Baptiste DERIOT, Dr.	Centre d'Ophtalmologie Blatin	Principal Investigator
Emmanuelle ALBERTINI, Dr.	Centre d'Ophtalmologie Blatin	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Ophtalmologie Blatin		Clermont-Ferrand		63000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39310045	Derived	Deriot JB, Albertini E. Is CONNECTDROP(R), a Medication Event Monitoring System Add-On Paired with a Smartphone Application, Acceptable to Patients with Glaucoma for Taking Their Daily Medication? The CONDORE Pilot Study. Ophthalmol Sci. 2024 Apr 30;4(6):100541. doi: 10.1016/j.xops.2024.100541. eCollection 2024 Nov-Dec.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases