Keratoconjunctivitis Sicca (KCS)NCT03418259
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)
A study testing KCS Medical Device in people with Keratoconjunctivitis Sicca (KCS), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Keratoconjunctivitis Sicca (KCS)
- What is being tested?
- KCS Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 12 Feb 2018to 1 Jul 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular surface disease index, OSDI > 12 points.
- Non-invasive breakup time, NIBUT < 11 seconds.
Who cannot join
- Ocular surface disease index, OSDI < 12 points.
- Non-invasive breakup time, NIBUT > 11 seconds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.
- Conditions
- Keratoconjunctivitis Sicca (KCS)
- Being tested
- KCS Medical Device
- Medical subject headings
- Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KCS Medical DeviceDevice
Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
KCS Medical DeviceDevice
Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active KCS Medical Device | Experimental | Not described Receives: Device: KCS Medical Device |
| Inactive KCS Medical Device | Placebo comparator | Not described Receives: Device: KCS Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface disease index, OSDI
12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Scale 0-100, normal value range 0-12.
Measured: Change from Baseline Ocular surface disease index at two weeks.
Secondary outcomes (6)
Noninvasive breakup time, NIBUT
Assessment of tear film stability. Normal value at least 11 seconds.
Measured: Change from Baseline Noninvasive breakup time at two weeks.
Meibography
Imaging study method for directly visualizing the morphology of Meibomian glands in vivo. Fat amount in the Meibomian glands is quantified and stated in percent. A Meibo scale value over 25 % is considered abnormal.
Measured: Change from Baseline Meibo scale value at two weeks.
Phenol Red Thread Test, PRT
Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.
Measured: Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.
Tear (lacrimal) meniscus height
Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.
Measured: Change from Baseline Tear (lacrimal) meniscus height at two weeks.
Lissamin green test
A strip of paper containing lissamine green is diluted with saline, and then dropped into the eye. The colour of the paper will disclose any dry cell patches in the eye.
Measured: Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.
Corneal staining with fluorescein
Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value.
Measured: Change from Baseline Efron Grading Scale value at two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start12 Feb 2018
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis Sicca (KCS)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomised clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Källmark Clinic
- Responsible party
- Principal investigator, Jan-Erik Juto, Karolinska Institutet
- Investigators
- Jan-Erik Juto, M.D., Ph.D., Principal investigator, Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418259
- Sponsor's protocol ID
- INMESTfordryeyes2018
- Status last verified
- Dec 2022
- First submitted
- 19 Jan 2018
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
- ClinicalTrials.gov ID
- NCT03418259
- Acronym / sponsor ID
- INMESTfordryeyes2018
- Conditions
- Keratoconjunctivitis Sicca (KCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Källmark Clinic
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 1 Feb 2018 (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 evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blinded randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active KCS Medical Device | Experimental | Device: KCS Medical Device |
| Inactive KCS Medical Device | Placebo comparator | Device: KCS Medical Device |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ocular surface disease index, OSDI > 12 points.
- Non-invasive breakup time, NIBUT < 11 seconds.
Key exclusion criteria (2 listed)
- Ocular surface disease index, OSDI < 12 points.
- Non-invasive breakup time, NIBUT > 11 seconds.
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 |
|---|---|---|
| KCS Medical DevicePatient treated 6 times with the Active KCS Medical Device during 2 weeks. | Device | Active KCS Medical Device |
| KCS Medical DevicePatient treated 6 times with the Inactive KCS Medical Device during 2 weeks. | Device | Inactive KCS Medical Device |
Primary outcome
Ocular surface disease index, OSDI
Time frame: Change from Baseline Ocular surface disease index at two weeks.
12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Scale 0-100, normal value range 0-12.
6 secondary outcomes
Noninvasive breakup time, NIBUT
Time frame: Change from Baseline Noninvasive breakup time at two weeks.
Meibography
Time frame: Change from Baseline Meibo scale value at two weeks.
Phenol Red Thread Test, PRT
Time frame: Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.
Tear (lacrimal) meniscus height
Time frame: Change from Baseline Tear (lacrimal) meniscus height at two weeks.
Lissamin green test
Time frame: Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.
Corneal staining with fluorescein
Time frame: Change from Baseline Efron Grading Scale value at two weeks.
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 13 Dec 2022.
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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.
Jan-Erik Juto, M.D., Ph.D. principal investigator
Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KCS Medical Device in people with Keratoconjunctivitis Sicca (KCS), run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 2 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 13 Dec 2022. 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 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?
Ocular surface disease index, OSDI (time frame: Change from Baseline Ocular surface disease index at two 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 13 Dec 2022.