Clinical trial NCT04552964: Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
Official title: Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single centre, single-arm, prospective pilot study.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global patient satisfaction
timeFrame: Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre d'Ophtalmologie Blatin
Study officials:
affiliation: Centre d'Ophtalmologie Blatin
name: Jean-Baptiste DERIOT, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Ophtalmologie Blatin
name: Emmanuelle ALBERTINI, Dr.
role: PRINCIPAL_INVESTIGATOR
References: