GlaucomaCONDORENCT04552964
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
A study testing Single arm in people with Glaucoma, run by Laboratoires Thea at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Single arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2020to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Single arm
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | This will be a single centre, single-arm, prospective pilot study. Receives: Other: Single arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global patient satisfaction
Global patient satisfaction (Patient satisfaction questionnaire)
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start25 Sep 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a single centre, single-arm, prospective pilot study.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste DERIOT, Dr., Principal investigator, Centre d'Ophtalmologie BlatinEmmanuelle ALBERTINI, Dr., Principal investigator, Centre d'Ophtalmologie Blatin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552964
- Sponsor's protocol ID
- CONDORE
- Acronym
- CONDORE
- Status last verified
- Jul 2021
- First submitted
- 3 Aug 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39310045
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
- ClinicalTrials.gov ID
- NCT04552964
- Acronym / sponsor ID
- CONDORE / CONDORE
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a single centre, single-arm, prospective pilot study.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: Single armThis will be a single centre, single-arm, prospective pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single armFar Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire | Other | Single arm |
Primary outcome
Global patient satisfaction
Time frame: Week 9
Global patient satisfaction (Patient satisfaction questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Derived from this study: PubMed 39310045Deriot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste DERIOT, Dr. principal investigator
Centre d'Ophtalmologie Blatin
Emmanuelle ALBERTINI, Dr. principal investigator
Centre d'Ophtalmologie Blatin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single arm in people with Glaucoma, run by Laboratoires Thea at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global patient satisfaction (time frame: Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04552964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.