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

Sponsor

Karolinska Institutet (Other)

Overall Status

Unknown status

CT.gov ID

NCT03418259

Collaborator

Källmark Clinic (Other)

120

Enrollment

Location

Arms

46.6

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca (KCS)	Device: KCS Medical Device Device: KCS Medical Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blinded randomised clinical trialDouble blinded randomised clinical trial

Masking:

Double (Participant, Investigator)

Masking Description:

Placebo device

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active KCS Medical Device	Device: KCS Medical Device Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
Placebo Comparator: Inactive KCS Medical Device	Device: KCS Medical Device Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.

Arm

Intervention/Treatment

Experimental: Active KCS Medical Device

Device: KCS Medical Device

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

Placebo Comparator: Inactive KCS Medical Device

Device: KCS Medical Device

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Noninvasive breakup time, NIBUT [Change from Baseline Noninvasive breakup time at two weeks.]
Assessment of tear film stability. Normal value at least 11 seconds.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Källmarkskliniken	Stockholm		Sweden

Sponsors and Collaborators

Karolinska Institutet
Källmark Clinic

Investigators

Principal Investigator: Jan-Erik Juto, M.D., Ph.D., Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jan-Erik Juto, Principal Investigator, M.D., Ph.D., Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT03418259

Other Study ID Numbers:

INMESTfordryeyes2018

First Posted:

Feb 1, 2018

Last Update Posted:

Feb 11, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Feb 11, 2020