Dry Eye SyndromesQUALVIDONNCT03296111
Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
An observational study of Dry Eye Syndromes and Neuralgia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Neuralgia, Pain
- What is being tested?
- Questionnaires on pain and quality of life
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2017to 28 Oct 2019
- Phase
- Observational
- 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
Study population: Adult patients with ocular neuropathic pain.
Who may be able to join
- Patient aged 18 years or older,
- Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia
- French language-skills
Who cannot join
- Severe corneal or palpebral damage explaining current pain
Trial locations and contacts
1 site in 1 country.
About this study
Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.
The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.
- Conditions
- Dry Eye Syndromes, Neuralgia, Pain, Quality of Life
- Being tested
- Questionnaires on pain and quality of life
- Medical subject headings
- Dry Eye Syndromes, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on pain and quality of lifeOther
Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life.
They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation).
Patients will be asked to complete several questionnaires :
- Questionnaire about the characteristics of ocular neuropathic pain (7 items)
- DEQ-5 (Dry Eye Questionnaire)
- ODI (Ocular Surface Disease Index)
- BPI (Brief Pain Inventory)
- HADS (Hospital Anxiety and Depression Scale)
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores obtained with each questionnaires.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start4 May 2017
- Primary completion19 Jun 2017
- Study completion28 Oct 2019
Why it stopped: Difficulties for patients inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296111
- Sponsor's protocol ID
- SDN_2017_9
- Acronym
- QUALVIDON
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2017
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
- ClinicalTrials.gov ID
- NCT03296111
- Acronym / sponsor ID
- QUALVIDON / SDN_2017_9
- Conditions
- Dry Eye Syndromes, Neuralgia, Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties for patients inclusion
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 4 May 2017 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 28 Sep 2017 (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.
Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.
The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ocular neuropathic pain.
Key inclusion criteria (3 listed)
- Patient aged 18 years or older,
- Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia
- French language-skills
Key exclusion criteria (1 listed)
- Severe corneal or palpebral damage explaining current pain
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 |
|---|---|---|
| Questionnaires on pain and quality of lifePatients will be asked to complete several questionnaires about their pain and the impact on their quality of life. They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation). Patients will be asked to complete several questionnaires : * Questionnaire about the characteristics of ocular neuropathic pain (7 items) * DEQ-5 (Dry Eye Questionnaire) * ODI (Ocular Surface Disease Index) * BPI (Brief Pain Inventory) * HADS (Hospital Anxiety and Depression Scale) | Other | – |
Primary outcome
Scores obtained with each questionnaires.
Time frame: baseline
Results and safety
The study was stopped early (reason given: Difficulties for patients inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes and Neuralgia, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Oct 2019. 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 was stopped early (reason given: Difficulties for patients inclusion). Results are not available in the source record.
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?
Scores obtained with each questionnaires. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.