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Procedure

Light Therapy + MGX for Dry Eye Disease

N/A

Recruiting

Research Sponsored by Candela Corporation

Eligibility Criteria Checklist

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

Must have

Has MGS ≤ 12 at screening/ baseline

Able and willing to comply with the treatment/follow-up schedule and requirements comply with all study (protocol) requirements

Must not have

Unwilling to discontinue use of contact lenses for the duration of the study

Planned radiation therapy, within 8 weeks after the last treatment session

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month follow up at week 10, and 3 month follow up at week 18

Summary

This trial studies a new light therapy to treat dry eye caused by a blocked oil gland.

Who is the study for?

Adults aged 18-75 with dry eye disease due to meibomian gland dysfunction can join this trial. They should have a certain level of dryness and gland function, be willing to follow the study schedule, consent to photos for research use, and not wear contact lenses during the study. People with recent eye surgeries or infections, skin cancer in the treatment area, uncontrolled diseases, light-sensitive conditions or treatments are excluded.

What is being tested?

The clinical trial is testing Nordlys SWT IPL technology against a sham (fake) treatment for improving dry eye symptoms caused by meibomian gland dysfunction. Participants will also undergo Meibomian Gland Expression (MGX), which is a procedure to clear blocked glands.

What are the potential side effects?

Possible side effects from Nordlys SWT IPL may include mild discomfort during treatment, temporary redness or swelling in treated areas. The MGX procedure might cause brief pain or irritation.

Eligibility Criteria

Inclusion Criteria

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

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My MGS score is 12 or less.

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I can follow the study's treatment and follow-up schedule.

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I have at least 5 healthy oil glands in my lower eyelid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing to stop wearing contact lenses during the study.

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I am scheduled for radiation therapy within 2 months after my last treatment.

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I haven't had any heat treatments on my eyelids in the last 6 months.

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I have severe eye or eyelid inflammation.

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I have an eyelid condition that affects its function.

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I haven't taken any medication or herbs that increase sensitivity to light in the last 3 months.

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I have not had chemotherapy in the last 8 weeks.

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I have a history of migraines, seizures, or epilepsy.

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I have an eye condition that could affect my cornea's health.

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I am legally blind in one eye.

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I have skin issues like pre-cancerous spots or skin cancer where I will be treated.

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I do not have any uncontrolled infections or immune system diseases.

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I have not had eye or eyelid surgery in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month follow up at week 10, and 3 month follow up at week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month follow up at week 10, and 3 month follow up at week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month follow up at week 10, and 3 month follow up at week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up

Secondary study objectives

Difference in change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up.

The difference in change of self-assessed symptoms of eye dryness via Eye Dryness Score (EDS) via visual analog scale (VAS), from baseline to follow-up