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Completed

NCT Number: NCT03418259

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

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.

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Key information

Conditions

Keratoconjunctivitis Sicca (KCS) Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Källmarkskliniken

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KCS Medical Device

Device

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

Primary outcomes

  1. Ocular surface disease index, OSDI

    Time frame: 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 outcomes

  1. Noninvasive breakup time, NIBUT

    Time frame: Change from Baseline Noninvasive breakup time at two weeks.

    Assessment of tear film stability. Normal value at least 11 seconds.

  2. Meibography

    Time frame: 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.

  3. Phenol Red Thread Test, PRT

    Time frame: 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.

  4. Tear (lacrimal) meniscus height

    Time frame: 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.

  5. Lissamin green test

    Time frame: 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.

  6. Corneal staining with fluorescein

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Källmark Clinic

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2018
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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