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

Keratoconjunctivitis Sicca (KCS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418259
• Other study ID #: INMESTfordryeyes2018
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Keratoconjunctivitis Sicca (KCS)

Intervention

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

Locations

Country	Name	City	State
Sweden	Källmarkskliniken	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Källmark Clinic

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Noninvasive breakup time, NIBUT	Assessment of tear film stability. Normal value at least 11 seconds.	Change from Baseline Noninvasive breakup time at two weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.