NCT04552964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

August 3, 2020

Last Update Submit

July 13, 2021

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Global patient satisfaction

    Global patient satisfaction (Patient satisfaction questionnaire)

    Week 9

Study Arms (1)

Single arm

OTHER

This will be a single centre, single-arm, prospective pilot study.

Other: Single arm

Interventions

Single armOTHER

Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Ophtalmologie Blatin

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

  • 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.

    PMID: 39310045DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jean-Baptiste DERIOT, Dr.

    Centre d'Ophtalmologie Blatin

    PRINCIPAL INVESTIGATOR

  • Emmanuelle ALBERTINI, Dr.

    Centre d'Ophtalmologie Blatin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This will be a single centre, single-arm, prospective pilot study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

September 17, 2020

Study Start

September 25, 2020

Primary Completion

April 27, 2021

Study Completion

April 27, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations

FR(1)