Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)

Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03418259

Enrollment

Registered

2018-02-01

Start date

2018-02-12

Completion date

2022-07-01

Last updated

2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca (KCS)

Brief 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.

Interventions

DEVICEKCS Medical Device

Patient treated 6 times with the Active KCS Medical Device during 2 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Placebo device

Intervention model description

Double blinded randomised clinical trial

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Ocular surface disease index, OSDI \> 12 points. * Non-invasive breakup time, NIBUT \< 11 seconds.

Exclusion criteria

* Ocular surface disease index, OSDI \< 12 points. * Non-invasive breakup time, NIBUT \> 11 seconds.

Design outcomes

Primary

Measure	Time frame	Description
Ocular surface disease index, OSDI	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.

Secondary

Measure	Time frame	Description
Meibography	Change from Baseline Meibo scale value at two weeks.	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.
Phenol Red Thread Test, PRT	Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.	Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.
Noninvasive breakup time, NIBUT	Change from Baseline Noninvasive breakup time at two weeks.	Assessment of tear film stability. Normal value at least 11 seconds.
Lissamin green test	Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.	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.
Corneal staining with fluorescein	Change from Baseline Efron Grading Scale value at two weeks.	Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value.
Tear (lacrimal) meniscus height	Change from Baseline Tear (lacrimal) meniscus height at two weeks.	Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026