Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye

Abilion Medical Systems

Status: Completed

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Drug: Non preserved ocular lubricants; Procedure: Eye lid procedure; Device: Sham Walther System; Device: Walther System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05887336

A-DE-002

Details and patient eligibility

About

The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).

A total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. Both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. The subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18
2. The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
3. History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
4. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
5. OSDI score > 15
6. Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
7. Anticipated compliance with prescribed treatment and follow-up

Exclusion criteria

1. Recently (3 months prior enrolment) undergone nasal or sinus surgery
2. Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
3. Ongoing acute upper respiratory tract infection, per the Investigator's judgement
4. Bleph-ex treated within 3 months prior to enrolment
5. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
6. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
7. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
8. Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Investigational device treament and standard treatment

Active Comparator group

Description:

After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.

Treatment:

Device: Walther System

Procedure: Eye lid procedure

Drug: Non preserved ocular lubricants

Sham device treatment and standard treatment

Sham Comparator group

Description:

After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.

Treatment:

Procedure: Eye lid procedure

Device: Sham Walther System

Drug: Non preserved ocular lubricants