Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma (CONDORE)

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Other: Single arm

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre d'Ophtalmologie Blatin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient with any eye condition in addition to glaucoma requiring expected additional treatment
2. Patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection.
3. Patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months
4. Patient with best-correct visual acuity <20/70 in the better seeing eye
5. Patient whose drop administration is performed by someone else
6. Alcohol addiction and/or heavy smoker, according to the investigator's judgement.
7. Patient inability to understand the study procedures or to give informed consent.
8. Non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance).
9. Participation in this study at the same time as in another clinical study.
10. 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.
11. Patient not covered by the government health care scheme of the country in which he/she is living (if applicable).
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single arm; This will be a single centre, single-arm, prospective pilot study.	Other: Single arm; Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laboratoires Thea
• Investigators: Principal Investigator: Jean-Baptiste DERIOT, Dr., Centre d'Ophtalmologie Blatin; Principal Investigator: Emmanuelle ALBERTINI, Dr., Centre d'Ophtalmologie Blatin

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2020
• Primary Completion (ACTUAL): April 27, 2021
• Study Completion (ACTUAL): April 27, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: CONDORE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No