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

Karolinska Institute

Status: Completed

Conditions: Keratoconjunctivitis Sicca (KCS)

Treatments: Device: KCS Medical Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03418259

INMESTfordryeyes2018

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

Active KCS Medical Device

Experimental group

Treatment:

Device: KCS Medical Device

Device: KCS Medical Device

Inactive KCS Medical Device

Placebo Comparator group

Treatment:

Device: KCS Medical Device

Device: KCS Medical Device