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

Not Applicable

Completed

• Conditions: Keratoconjunctivitis Sicca (KCS)
• Interventions: Device: KCS Medical Device

• Registration Number: NCT03418259
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-02-12
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-11
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active KCS Medical Device	KCS Medical Device	-
Inactive KCS Medical Device	KCS Medical Device	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Källmarkskliniken; 🇸🇪 Stockholm, Sweden