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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single arm
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre d'Ophtalmologie Blatin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Global patient satisfaction
Global patient satisfaction (Patient satisfaction questionnaire)

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
July 13, 2021
Sponsor
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT04552964
Brief Title
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
Acronym
CONDORE
Official Title
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a single centre, single-arm, prospective pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
This will be a single centre, single-arm, prospective pilot study.
Intervention Type
Other
Intervention Name(s)
Single arm
Intervention Description
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 Outcome Measure Information:
Title
Global patient satisfaction
Description
Global patient satisfaction (Patient satisfaction questionnaire)
Time Frame
Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste DERIOT, Dr.
Organizational Affiliation
Centre d'Ophtalmologie Blatin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuelle ALBERTINI, Dr.
Organizational Affiliation
Centre d'Ophtalmologie Blatin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Ophtalmologie Blatin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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