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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Other: Single arm

• Registration Number: NCT04552964
• Lead Sponsor: Laboratoires Thea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-17
• Study Start: 2020-09-25
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Single arm	This will be a single centre, single-arm, prospective pilot study.

Primary Outcome Measures

Name	Time	Method
Global patient satisfaction	Week 9	Global patient satisfaction (Patient satisfaction questionnaire)

Trial Locations

Locations (1)

Centre d'Ophtalmologie Blatin; 🇫🇷 Clermont-Ferrand, France