Dry EyeNCT05887336
Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye
A study testing Walther System, Non preserved ocular lubricants and Eye lid procedure in people with Dry Eye and Dry Eye Syndromes, run by Abilion Medical Systems AB at 3 sites in 2 countries.
Trial summary
The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- Walther System, Non preserved ocular lubricants and Eye lid procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2023to 31 Oct 2024
- 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
- Age ≥ 18
- The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
- History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
- Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
- OSDI score > 15
- Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
- Anticipated compliance with prescribed treatment and follow-up
Who cannot join
- Recently (3 months prior enrolment) undergone nasal or sinus surgery
- Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
- Ongoing acute upper respiratory tract infection, per the Investigator's judgement
- Bleph-ex treated within 3 months prior to enrolment
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
- The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
- Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
- Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Kontaktlinse Instituttet
Aarhus, Århus
Øjenhospitalet Danmark
Charlottenlund, Copenhagen, 2920
About this study
Official title: Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye - a Prospective, Double-blind, Pivotal Study to Evaluate the Safety and Performance of the Walther System
The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).
A total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. Both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. The subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Walther System, Sham Walther System, Non preserved ocular lubricants, Eye lid procedure
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walther SystemDevice
Walther System providing INMEST treatment
Sham Walther SystemDevice
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
Non preserved ocular lubricantsDrug
- Hyaluronic acid (HyloGel)
- Hyaluronic acid and Ectoin (Hylo Dual Intense)
- Hyaluronic acid and Trehalos (Theloz Duo)
Eye lid procedureProcedure or surgery
Lid hygiene, warm eye bag, lid massage and Omega 3
| Study group | Role | What they receive |
|---|---|---|
| Investigational device treament and standard treatment | Active comparator | After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks. Receives: Device: Walther System; Drug: Non preserved ocular lubricants; Procedure: Eye lid procedure |
| Sham device treatment and standard treatment | Sham comparator | After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks. Receives: Device: Sham Walther System; Drug: Non preserved ocular lubricants; Procedure: Eye lid procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Surface Disease Index (OSDI)
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
Measured: Treatment period, up to 6 weeks
Secondary outcomes (22)
Adverse Events
Number of treatment related Adverse Events/Adverse Device Effects/Serious Adverse Events/Serious Adverse Device Effects and Unanticipated Serious Adverse Device Effects when using the Walther System.
Measured: Study period, up to 4.5 months
Device Deficiencies
Number of Walther System Device Deficiencies.
Measured: Treatment period, up to 6 weeks
Remission
Remission of estimated symptoms with OSDI after a treatment period of 6 weeks evaluated as a binary endpoint.
Measured: Treatment period, up to 6 weeks
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time. Baseline result compared to result measured during treatment period.
Measured: Treatment period, up to 6 weeks
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period.
Measured: Treatment period, up to 6 weeks
Tear Meniscus Height (TMH)
Degree of change in TMH value. Baseline value compared to value measured during treatment period.
Measured: Treatment period, up to 6 weeks
Lissamine Green Test
Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.
Measured: Treatment period, up to 6 weeks
Corneal Staining Test
Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.
Measured: Treatment period, up to 6 weeks
Lipid Layer Test
Degree of improvement of Lipid Layer coverage and thickness. Baseline result compared to results measured during the treatment period.
The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe
Measured: Treatment period, up to 6 weeks
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time evaluated at 1 month after end of treatment period.
Measured: Follow-up period, up to 1 month
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time evaluated at 3 months after end of treatment period.
Measured: Follow-up period, up to 3 months
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test evaluated at 1 month after end of treatment period.
Measured: Follow-up period, up to 1 month
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test evaluated at 3 months after end of treatment period.
Measured: Follow-up period, up to 3 months
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 1 month after end of treatment period.
Measured: Follow-up period, up to 1 month
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 3 months after end of treatment period.
Measured: Follow-up period, up to 3 months
Lissamine Green Test
Lissamine green test scale changes evaluated at 1 month after end of treatment period.
Measured: Follow-up period, up to 1 month
Lissamine Green Test
Lissamine green test scale changes evaluated at 3 months after end of treatment period.
Measured: Follow-up period, up to 3 months
Corneal Staining Test
Corneal Staining test scale changes evaluated at 1 month after end of treatment period.
Measured: Follow-up period, up to 1 month
Corneal Staining Test
Corneal Staining test scale changes evaluated at 3 months after end of treatment period.
Measured: Follow-up period, up to 3 months
Lipid Layer Test
Degree of improvement of Lipid Layer coverage and thickness evaluated at 1 month after end of treatment.
The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe
Measured: Follow-up period, up to 1 month
Lipid Layer Test
Degree of improvement of Lipid Layer coverage and thickness evaluated at 3 months after end of treatment.
The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe
Measured: Follow-up period, up to 3 months
Compliance
Grade of compliance/adherence to prescribed treatment.
Measured: Study period, up to 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Aug 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pivotal, double-blind, randomized, multicentre study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abilion Medical Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredrik Källmark, PhD, Principal investigator, Källmarkskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887336
- Sponsor's protocol ID
- A-DE-002
- Status last verified
- Nov 2024
- First submitted
- 23 May 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye - a Prospective, Double-blind, Pivotal Study to Evaluate the Safety and Performance of the Walther System
- ClinicalTrials.gov ID
- NCT05887336
- Acronym / sponsor ID
- A-DE-002
- Conditions
- Dry Eye, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Abilion Medical Systems ABIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 2 Jun 2023 (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.
The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).
A total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. Both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. The subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pivotal, double-blind, randomized, multicentre study.
| Arm | Type | Receives |
|---|---|---|
| Investigational device treament and standard treatment | Active comparator | Device: Walther System, Drug: Non preserved ocular lubricants, Procedure: Eye lid procedureAfter an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks. |
| Sham device treatment and standard treatment | Sham comparator | Device: Sham Walther System, Drug: Non preserved ocular lubricants, Procedure: Eye lid procedureAfter an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
- History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
- Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
- OSDI score > 15
Key exclusion criteria (8 listed)
- Recently (3 months prior enrolment) undergone nasal or sinus surgery
- Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
- Ongoing acute upper respiratory tract infection, per the Investigator's judgement
- Bleph-ex treated within 3 months prior to enrolment
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
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 |
|---|---|---|
| Walther SystemWalther System providing INMEST treatment | Device | Investigational device treament and standard treatment |
| Sham Walther SystemWalther System not providing INMEST treatment, but otherwise behave as the active comparator. | Device | Sham device treatment and standard treatment |
| Non preserved ocular lubricants* Hyaluronic acid (HyloGel) * Hyaluronic acid and Ectoin (Hylo Dual Intense) * Hyaluronic acid and Trehalos (Theloz Duo) | Drug | Investigational device treament and standard treatment, Sham device treatment and standard treatment |
| Eye lid procedureLid hygiene, warm eye bag, lid massage and Omega 3 | Procedure or surgery | Investigational device treament and standard treatment, Sham device treatment and standard treatment |
Primary outcome
Change in Ocular Surface Disease Index (OSDI)
Time frame: Treatment period, up to 6 weeks
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
22 secondary outcomes
Adverse Events
Time frame: Study period, up to 4.5 months
Device Deficiencies
Time frame: Treatment period, up to 6 weeks
Remission
Time frame: Treatment period, up to 6 weeks
Non-Invasive Tear Break-Up time (NIBUT)
Time frame: Treatment period, up to 6 weeks
Schirmer's Test
Time frame: Treatment period, up to 6 weeks
Tear Meniscus Height (TMH)
Time frame: Treatment period, up to 6 weeks
Lissamine Green Test
Time frame: Treatment period, up to 6 weeks
Corneal Staining Test
Time frame: Treatment period, up to 6 weeks
Lipid Layer Test
Time frame: Treatment period, up to 6 weeks
Non-Invasive Tear Break-Up time (NIBUT)
Time frame: Follow-up period, up to 1 month
Non-Invasive Tear Break-Up time (NIBUT)
Time frame: Follow-up period, up to 3 months
Schirmer's Test
Time frame: Follow-up period, up to 1 month
Schirmer's Test
Time frame: Follow-up period, up to 3 months
Tear Meniscus Height (TMH)
Time frame: Follow-up period, up to 1 month
Tear Meniscus Height (TMH)
Time frame: Follow-up period, up to 3 months
Lissamine Green Test
Time frame: Follow-up period, up to 1 month
Lissamine Green Test
Time frame: Follow-up period, up to 3 months
Corneal Staining Test
Time frame: Follow-up period, up to 1 month
Corneal Staining Test
Time frame: Follow-up period, up to 3 months
Lipid Layer Test
Time frame: Follow-up period, up to 1 month
Lipid Layer Test
Time frame: Follow-up period, up to 3 months
Compliance
Time frame: Study period, up to 4.5 months
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 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Fredrik Källmark, PhD principal investigator
Källmarkskliniken
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walther System, Non preserved ocular lubricants and Eye lid procedure in people with Dry Eye and Dry Eye Syndromes, run by Abilion Medical Systems AB at 3 sites in 2 countries.
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 7 inclusion and 8 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden. 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. Some participants in this study may receive a placebo. 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?
Change in Ocular Surface Disease Index (OSDI) (time frame: Treatment period, up to 6 weeks). 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 5 Nov 2024.