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

NCT05887336 | Completed DMC

• 1 other identifier: A-DE-002
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI)

  Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.

  Treatment period, up to 6 weeks

Secondary Outcomes (22)

• Adverse Events

  Study period, up to 4.5 months

• Device Deficiencies

  Treatment period, up to 6 weeks

• Remission

  Treatment period, up to 6 weeks

• Non-Invasive Tear Break-Up time (NIBUT)

  Treatment period, up to 6 weeks

• Schirmer's Test

  Treatment period, up to 6 weeks

Study Arms (2)

Investigational device treament and standard treatment

ACTIVE COMPARATOR

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.

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

Sham device treatment and standard treatment

SHAM COMPARATOR

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.

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

Interventions

Walther System DEVICE

Walther System providing INMEST treatment

Investigational device treament and standard treatment

Sham Walther System DEVICE

Walther System not providing INMEST treatment, but otherwise behave as the active comparator.

Sham device treatment and standard treatment

Non preserved ocular lubricants DRUG

* Hyaluronic acid (HyloGel) * Hyaluronic acid and Ectoin (Hylo Dual Intense) * Hyaluronic acid and Trehalos (Theloz Duo)

Investigational device treament and standard treatment; Sham device treatment and standard treatment

Eye lid procedure PROCEDURE

Lid hygiene, warm eye bag, lid massage and Omega 3

Investigational device treament and standard treatment; Sham device treatment and standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
• 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
• Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
• OSDI score \> 15
• Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
• Anticipated compliance with prescribed treatment and follow-up

You may not qualify if:

• Recently (3 months prior enrolment) undergone nasal or sinus surgery
• Ongoing acute upper respiratory tract infection, per the Investigator's judgement
• Bleph-ex treated within 3 months prior to enrolment
• The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
• The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
• Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
• Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s

Sponsors & Collaborators

• Abilion Medical Systems AB: lead

Study Sites (3)

Øjenhospitalet Danmark

Charlottenlund, Copenhagen, 2920, Denmark

Location

Kontaktlinse Instituttet

Aarhus, Århus, Denmark

Location

Källmarkskliniken

Solna, Stockholm County, 171 54, Sweden

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Fredrik Källmark, PhD

  Källmarkskliniken

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal, double-blind, randomized, multicentre study.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DK (2)