Skip to main content
OpenTrials
Completed

NCT Number: NCT04552964

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Ophtalmologie Blatin

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Global patient satisfaction

    Time frame: Week 9

    Global patient satisfaction (Patient satisfaction questionnaire)

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Acronym: CONDORE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.