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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Sweden1 site

Källmarkskliniken
Stockholm

Other trials in Sweden

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 groups in NCT03418259
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.

12 Feb 20181 Jul 2022

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)

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.

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?

On the ClinicalTrials.gov record for NCT03418259.

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; AzTrials last refreshed its copy on 8 Nov 2026.