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Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nordlys SWT IPL
Meibomian Gland Expression (MGX)
Sponsored by
Candela Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI. Able and willing to comply with the treatment/follow-up schedule and requirements comply with all study (protocol) requirements. Willingness to provide signed, informed consent to participate in the study Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials Has TBUT ≤ 7 seconds at screening/baseline Has MGS ≤ 12 at screening/ baseline Has at least 5 non-atrophied meibomian glands and at least 50% of working meibomian glands in the lower eyelid at screening/ baseline Symptoms self-assessed using the OSDI questionnaire ≥ 23 at screening/ baseline Exclusion Criteria: Contact lens wear within the month prior to screening Unwilling to discontinue use of contact lenses for the duration of the study Ocular surgery or eyelid surgery, within 6 months prior to screening Neuro-paralysis in the planned treatment area, within 6 months prior to screening Other uncontrolled eye disorders affecting the ocular surface, for example active allergies Current use of punctal plugs Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area Uncontrolled infections or uncontrolled immunosuppressive diseases Subjects with ocular infections, within 6 months prior to screening Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria unless treated following a prophylactic regimen per principal investigator discretion. Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort Over exposure to sun, within 4 weeks prior to screening Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops Radiation therapy to the head or neck, within 12 months prior to screening Planned radiation therapy, within 8 weeks after the last treatment session Treatment with chemotherapeutic agent, within 8 weeks prior to screening Planned chemotherapy, within 8 weeks after the last treatment session New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears Change in dosage of any systemic medication, within 3 months prior to screening Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period Legally blind in either eye History of migraines, seizures or epilepsy Facial IPL treatment within 12 months prior to screening Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening Expression of the meibomian glands, within 6 months prior to screening In either eye, moderate to severe inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis or severe inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy) Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit. Any condition revealed whereby the investigator deems the subject inappropriate for this study

Sites / Locations

  • Center for Excellence in Eye CareRecruiting
  • Candela Institute of ExcellenceRecruiting
  • Av. Del Libertador 662, Piso 17, Dept. 42

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: Nordlys SWT IPL

Control Group: Sham Treatment

Arm Description

Subjects will receive up to four study Nordlys SWT IPL treatments and MGX

Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX

Outcomes

Primary Outcome Measures

Improvement of TBUT from baseline to 4-week follow up
The difference in the change of TBUT from BL to FU, between eyes in the study group and eyes in the control group. TBUT is measured in seconds. Improvement is defined as a positive change of TBUT from Baseline to Follow Up. Measurement of TBUT will be implemented using fluorescein ophthalmic strips. Three successive readings will be taken and averaged to a single value.

Secondary Outcome Measures

Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up.
The difference in the change of OSDI from baseline to FU, between subjects in the study group and subjects in the control group. The improvement of OSDI in the study group is larger than the improvement of OSDI in the control group, where improvement is defined as a negative change of OSDI from BL to FU
Change of self-assessed symptoms of eye dryness via Eye Dryness Score (EDS) via visual analog scale (VAS), from baseline to follow-up
The difference in the change of EDS from baseline to follow up, between subjects in the study group and subjects in the control group. The improvement of EDS in the study group is larger than the improvement of EDS in the control group, where improvement is defined as a negative change of EDS from BL to the FU

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Candela Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT06064071
Brief Title
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Official Title
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candela Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
Clinical Study Evaluating Nordlys™ System with Selective Waveband Technology (SWT)® Intense Pulsed Light (IPL) Applicators for Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD).
Detailed Description
Subjects will be randomized 1:1 to an experimental study group and a sham comparator (control) group. Subjects in the experimental group will receive four (4) IPL treatments and meibomian gland expression (MGX) at 2-week intervals. IPL pulses will be administered on the skin of the malar region and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Subjects in the control group will receive the same treatment (IPL followed by MGX), except that the IPL administration will be performed with the device off (sham treatment). Follow-up visits will occur at 1 month and 3 months after the final treatment session. At the follow-up, the changes in the outcome measures will be evaluated and compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Nordlys SWT IPL
Arm Type
Experimental
Arm Description
Subjects will receive up to four study Nordlys SWT IPL treatments and MGX
Arm Title
Control Group: Sham Treatment
Arm Type
Sham Comparator
Arm Description
Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX
Intervention Type
Device
Intervention Name(s)
Nordlys SWT IPL
Intervention Description
Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators
Intervention Type
Procedure
Intervention Name(s)
Meibomian Gland Expression (MGX)
Intervention Description
Meibomian glands are squeezed (by applying force on the inner and outer surfaces of the eyelid with a specially designed forceps, Q-tips, or fingers) in order to unclog obstructed glands and evacuate their content (the meibum), which in MGD is often viscous and thus causing obstruction
Primary Outcome Measure Information:
Title
Improvement of TBUT from baseline to 4-week follow up
Description
The difference in the change of TBUT from BL to FU, between eyes in the study group and eyes in the control group. TBUT is measured in seconds. Improvement is defined as a positive change of TBUT from Baseline to Follow Up. Measurement of TBUT will be implemented using fluorescein ophthalmic strips. Three successive readings will be taken and averaged to a single value.
Time Frame
Baseline, 4-Week Follow Up (Week 10)
Secondary Outcome Measure Information:
Title
Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up.
Description
The difference in the change of OSDI from baseline to FU, between subjects in the study group and subjects in the control group. The improvement of OSDI in the study group is larger than the improvement of OSDI in the control group, where improvement is defined as a negative change of OSDI from BL to FU
Time Frame
Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18
Title
Change of self-assessed symptoms of eye dryness via Eye Dryness Score (EDS) via visual analog scale (VAS), from baseline to follow-up
Description
The difference in the change of EDS from baseline to follow up, between subjects in the study group and subjects in the control group. The improvement of EDS in the study group is larger than the improvement of EDS in the control group, where improvement is defined as a negative change of EDS from BL to the FU
Time Frame
Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI. Able and willing to comply with the treatment/follow-up schedule and requirements comply with all study (protocol) requirements. Willingness to provide signed, informed consent to participate in the study Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials Has TBUT ≤ 7 seconds at screening/baseline Has MGS ≤ 12 at screening/ baseline Has at least 5 non-atrophied meibomian glands and at least 50% of working meibomian glands in the lower eyelid at screening/ baseline Symptoms self-assessed using the OSDI questionnaire ≥ 23 at screening/ baseline Exclusion Criteria: Contact lens wear within the month prior to screening Unwilling to discontinue use of contact lenses for the duration of the study Ocular surgery or eyelid surgery, within 6 months prior to screening Neuro-paralysis in the planned treatment area, within 6 months prior to screening Other uncontrolled eye disorders affecting the ocular surface, for example active allergies Current use of punctal plugs Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area Uncontrolled infections or uncontrolled immunosuppressive diseases Subjects with ocular infections, within 6 months prior to screening Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria unless treated following a prophylactic regimen per principal investigator discretion. Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort Over exposure to sun, within 4 weeks prior to screening Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops Radiation therapy to the head or neck, within 12 months prior to screening Planned radiation therapy, within 8 weeks after the last treatment session Treatment with chemotherapeutic agent, within 8 weeks prior to screening Planned chemotherapy, within 8 weeks after the last treatment session New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears Change in dosage of any systemic medication, within 3 months prior to screening Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period Legally blind in either eye History of migraines, seizures or epilepsy Facial IPL treatment within 12 months prior to screening Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening Expression of the meibomian glands, within 6 months prior to screening In either eye, moderate to severe inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis or severe inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy) Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit. Any condition revealed whereby the investigator deems the subject inappropriate for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Duffy
Phone
5089488185
Email
maya.duffy@candelamedical.com
Facility Information:
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Carolina Victoria, MD
Phone
305-598-2020
First Name & Middle Initial & Last Name & Degree
Ana Carolina Victoria, MD
Facility Name
Candela Institute of Excellence
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolle Dest
Phone
508-358-0357
Email
nicolled@candelamedical.com
First Name & Middle Initial & Last Name & Degree
Konika Patel Schallen, MD
Facility Name
Av. Del Libertador 662, Piso 17, Dept. 42
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agustina Echague, MD
First Name & Middle Initial & Last Name & Degree
Agustina Echague

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD

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