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

NCT ID: NCT03418259

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2022-07-01

Brief Summary

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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

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Conditions

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Keratoconjunctivitis Sicca (KCS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded randomised clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Placebo device

Study Groups

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Active KCS Medical Device

Group Type EXPERIMENTAL

KCS Medical Device

Intervention Type DEVICE

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

Inactive KCS Medical Device

Group Type PLACEBO_COMPARATOR

KCS Medical Device

Intervention Type DEVICE

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

Interventions

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KCS Medical Device

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

Intervention Type DEVICE

KCS Medical Device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Källmark Clinic

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Jan-Erik Juto

Principal Investigator, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan-Erik Juto, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet

Locations

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Källmarkskliniken

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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INMESTfordryeyes2018

Identifier Type: -

Identifier Source: org_study_id