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Therapeutic iLIDS arm for Blepharitis

Phase 1

Recruiting

Research Sponsored by Olympic Ophthalmics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must use iTEAR and NuLids at time of enrollment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is being done to test how well the iTEAR100 generation 2 device works when used with its new iLIDS100 disposable cover.

Who is the study for?

This clinical trial is for individuals who are experiencing Dry Eye Syndrome or Blepharitis. The study aims to assess the usability of a new device and its disposable cover, but specific eligibility criteria have not been provided.Check my eligibility

What is being tested?

The trial is testing the iTEAR100 generation 2 device with an added component called iLIDS100. This combination is designed for eyelid cleaning (microblepharoexfoliation) and nerve stimulation to potentially help with eye conditions.See study design

What are the potential side effects?

Since this is a usability study, side effects may include discomfort at the site of application or irritation related to the use of the device on eyelids. However, detailed potential side effects are not specified.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently using iTEAR and NuLids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Questionnaire

Trial Design

1Treatment groups

Experimental Treatment

Group I: Therapeutic iLIDS armExperimental Treatment1 Intervention

Subjects apply iTEAR100 device with iLIDS100 accessory

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Olympic Ophthalmics, Inc.Lead Sponsor

3 Previous Clinical Trials

165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently seeking eligible participants. The trial was initially posted on January 19th, 2024 and underwent its most recent revision on January 23rd, 2024. This study aims to enroll a total of 200 patients at a single designated site."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The initial posting of the study was made on January 19th, 2024, and it has been recently updated as of January 23rd, 2024. The research team aims to enroll a total of 200 patients from a single designated site."

Answered by AI

What is the safety profile of the therapeutic iLIDS arm in relation to patient well-being?

"The safety rating for the Therapeutic iLIDS arm is 1, as this trial is in Phase 1 with limited available data to support both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

2024. "A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235450.

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