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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month follow up at week 10, and 3 month follow up at week 18
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up
Secondary outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Nordlys SWT IPLExperimental Treatment2 Interventions
Subjects will receive up to four study Nordlys SWT IPL treatments and MGX
Group II: Control Group: Sham TreatmentPlacebo Group2 Interventions
Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX

Find a Location

Who is running the clinical trial?

Candela CorporationLead Sponsor
19 Previous Clinical Trials
1,865 Total Patients Enrolled

Frequently Asked Questions

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

Does the protocol for this research encompass seniors aged 80 and above?

"This research seeks to include individuals between 18 and 75 years old."

Answered by AI

Who would be an appropriate participant in this experiment?

"Patients who are afflicted with meibomian gland dysfunction and aged between 18 to 75 years old can apply for this clinical trial. A total of 100 volunteers will be accepted into the study."

Answered by AI

Is there still an opportunity for people to participate in this investigation?

"Affirmative. Information hosted on clinicaltrials.gov suggests that this research is actively seeking volunteers - it was first published on September 18th 2023 and the details were most recently updated two days ago, on September 26th 2023. This medical trial requires 100 patients from 3 different locations."

Answered by AI

What is the maximum amount of individuals who can participate in this trial?

"Affirmative. The information on clinicaltrials.gov affirms that this research project is actively recruiting participants, with its initial posting occurring 18th September 2023 and the most recent update taking place 26th of the same month. 100 patients must be enrolled from 3 different sites for successful completion of this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Excellence in Eye Care
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Chronic dry eye and MGD without relief.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
2023. "Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064071.
All > Dry Eye
~67 spots leftby Sep 2025
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