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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552964
Other study ID # CONDORE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date April 27, 2021

Study information

Verified date July 2021
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Centre d'Ophtalmologie Blatin Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global patient satisfaction Global patient satisfaction (Patient satisfaction questionnaire) Week 9
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