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)

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 Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca (KCS)
• Intervention / Treatment: Device: KCS Medical Device; Device: KCS Medical Device

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Källmarkskliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Device: KCS Medical Device; Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
Placebo Comparator: Inactive KCS Medical Device	Device: KCS Medical Device; Patient treated 6 times with the Active KCS Medical Device during 2 weeks.; Device: KCS Medical Device; Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline Ocular surface disease index at two weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive breakup time, NIBUT	Assessment of tear film stability. Normal value at least 11 seconds.	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.	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.	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.	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.	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.	Change from Baseline Efron Grading Scale value at two weeks.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
• Other Study ID Numbers: INMESTfordryeyes2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No