Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525961
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
iTear Single-center Open-label Single-arm Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Open-label Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effectiveness and safety of a device iTEAR100 Neurostimulator the device which is designed to help people with Dry Eye Disease DED who are not satisfied with using artificial tears The study will last three months and take place at one location Thirty participants will use the iTEAR100 Neurostimulator which stimulates the outside of the nose to help with dry eye symptoms
Participants will have three main visits one at the start Day 0 one after 30 days Day 30 and one at the end of the study Day 90 For the first 30 days they will use the device twice a day for 30 seconds on each side of the nose After that they will use it as needed for the next 60 days
Before starting the treatment participants will undergo tests to measure their initial eye condition The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90 Participants will also fill out a questionnaire about their eye symptoms on Day 14
The main measure of success is how much the participants symptoms improve on the Ocular Surface Disease Index OSDI from Day 0 to Day 30 Other measures include changes in tear production tear quality and eye health from Day 0 to Days 30 and 90 Participants safety will be monitored by tracking any adverse events side effects throughout the study
Participants will have three main visits one at the start Day 0 one after 30 days Day 30 and one at the end of the study Day 90 For the first 30 days they will use the device twice a day for 30 seconds on each side of the nose After that they will use it as needed for the next 60 days
Before starting the treatment participants will undergo tests to measure their initial eye condition The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90 Participants will also fill out a questionnaire about their eye symptoms on Day 14
The main measure of success is how much the participants symptoms improve on the Ocular Surface Disease Index OSDI from Day 0 to Day 30 Other measures include changes in tear production tear quality and eye health from Day 0 to Days 30 and 90 Participants safety will be monitored by tracking any adverse events side effects throughout the study
Detailed Description:
This is a Phase IV single-centre open-label single-arm study to evaluate the effectiveness and safety of extra nasal neurostimulation in relieving symptoms of patients with Dry Eye Disease DED who are dissatisfied with artificial tear treatment The intervention product is the extranasal neurostimulator branded iTEAR
The study duration is three months with visits on Days 0 30 and 90 Participants will follow a treatment regimen to apply neurostimulation to each side of the nose for 30 seconds twice daily for 30 days From Day 31 to Day 90 participants will use the device as needed Screening tests to measure baseline levels will be performed on Visit 1 and efficacy measures will be performed on Day 30 and Day 90 The participants will be instructed to perform a questionnaire on the ocular surface disease index OSDI on Day 14 Primary efficacy measures include changes in OSDI from baseline to Day 30 Secondary efficacy measures include the change in Schirmer Test Score tear lipid layer thickness cornealconjunctival staining and non-invasive tear film break-up time NIBUT from baseline to Day 30 and Day 90 Adverse Event AE Query is used as a safety measure to report adverse events in the duration of the study The estimation of subjects in this trial is 30 with a power of 08 and assuming a 20 dropout rate
To be included in the study participants must be able to provide informed consent to participate in the study They must have reported dissatisfaction OSDI 23 with the recent use of artificial tears for DED within 30 days of Visit 1 and Schirmer Test Score 10 mm5 min in at least one eye
The study eye will be defined as the eye with a Schirmer Test Score 10 mm5 min If both eyes qualify the eye with a lower Schirmer Test Score during screening will be chosen as the study eye If there is no difference the right eye will be selected as the study eye
The participants are excluded from the study if they have used extranasal or intranasal neurostimulator within 30 days of Visit 1 or participated in any clinical trial with an investigational substance or device within 30 days of Visit 1 In the opinion of the investigator any condition that could impair study participationocular evaluation or the potential risks of participation outweigh the potential benefits will also lead to exclusion from the study
The participants will be withdrawn from the study if they voluntarily withdraw their consent to study participation develop any adverse event that prevents the study participation persistently do not comply with the study protocol are lost to follow-up or when the investigator believes the risk of further subject participation outweighs the benefit
The study duration is three months with visits on Days 0 30 and 90 Participants will follow a treatment regimen to apply neurostimulation to each side of the nose for 30 seconds twice daily for 30 days From Day 31 to Day 90 participants will use the device as needed Screening tests to measure baseline levels will be performed on Visit 1 and efficacy measures will be performed on Day 30 and Day 90 The participants will be instructed to perform a questionnaire on the ocular surface disease index OSDI on Day 14 Primary efficacy measures include changes in OSDI from baseline to Day 30 Secondary efficacy measures include the change in Schirmer Test Score tear lipid layer thickness cornealconjunctival staining and non-invasive tear film break-up time NIBUT from baseline to Day 30 and Day 90 Adverse Event AE Query is used as a safety measure to report adverse events in the duration of the study The estimation of subjects in this trial is 30 with a power of 08 and assuming a 20 dropout rate
To be included in the study participants must be able to provide informed consent to participate in the study They must have reported dissatisfaction OSDI 23 with the recent use of artificial tears for DED within 30 days of Visit 1 and Schirmer Test Score 10 mm5 min in at least one eye
The study eye will be defined as the eye with a Schirmer Test Score 10 mm5 min If both eyes qualify the eye with a lower Schirmer Test Score during screening will be chosen as the study eye If there is no difference the right eye will be selected as the study eye
The participants are excluded from the study if they have used extranasal or intranasal neurostimulator within 30 days of Visit 1 or participated in any clinical trial with an investigational substance or device within 30 days of Visit 1 In the opinion of the investigator any condition that could impair study participationocular evaluation or the potential risks of participation outweigh the potential benefits will also lead to exclusion from the study
The participants will be withdrawn from the study if they voluntarily withdraw their consent to study participation develop any adverse event that prevents the study participation persistently do not comply with the study protocol are lost to follow-up or when the investigator believes the risk of further subject participation outweighs the benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None