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

Primary Purpose

Keratoconjunctivitis Sicca (KCS)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
KCS Medical Device
KCS Medical Device
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca (KCS)

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Källmarkskliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active KCS Medical Device

Inactive KCS Medical Device

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Noninvasive breakup time, NIBUT
Assessment of tear film stability. Normal value at least 11 seconds.
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.
Phenol Red Thread Test, PRT
Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.
Tear (lacrimal) meniscus height
Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.
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.
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.

Full Information

First Posted
January 19, 2018
Last Updated
December 11, 2022
Sponsor
Karolinska Institutet
Collaborators
Källmark Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03418259
Brief Title
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)
Official Title
Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Källmark Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca (KCS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomised clinical trial
Masking
ParticipantInvestigator
Masking Description
Placebo device
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active KCS Medical Device
Arm Type
Experimental
Arm Title
Inactive KCS Medical Device
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
KCS Medical Device
Intervention Description
Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
Intervention Type
Device
Intervention Name(s)
KCS Medical Device
Intervention Description
Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
Primary Outcome Measure Information:
Title
Ocular surface disease index, OSDI
Description
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.
Time Frame
Change from Baseline Ocular surface disease index at two weeks.
Secondary Outcome Measure Information:
Title
Noninvasive breakup time, NIBUT
Description
Assessment of tear film stability. Normal value at least 11 seconds.
Time Frame
Change from Baseline Noninvasive breakup time at two weeks.
Title
Meibography
Description
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.
Time Frame
Change from Baseline Meibo scale value at two weeks.
Title
Phenol Red Thread Test, PRT
Description
Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.
Time Frame
Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.
Title
Tear (lacrimal) meniscus height
Description
Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.
Time Frame
Change from Baseline Tear (lacrimal) meniscus height at two weeks.
Title
Lissamin green test
Description
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.
Time Frame
Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.
Title
Corneal staining with fluorescein
Description
Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value.
Time Frame
Change from Baseline Efron Grading Scale value at two weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan-Erik Juto, M.D., Ph.D.
Organizational Affiliation
Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Källmarkskliniken
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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