Clinical trial NCT03396913: Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
Official title: Effectiveness of Intense Pulsed Light for Improving Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Intense Pulsed Light
Meibomian Gland Dysfunction
Dry Eye Disease
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-11
Enrollment: 88
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.

Detailed description: Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with intense pulsed light (IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.

For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).

Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.

Eligibility criteria: Inclusion Criteria:

* Subject is able to read, understand and sign an Informed Consent (IC) form
* 22-85 years of age
* Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
* In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds
* In the study eye, Meibomian Gland Score (MGS) ≤ 12
* In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
* Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23

Exclusion Criteria:

* Fitzpatrick skin type V or VI
* 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
* 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 (Grade 3-4) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
* In either eye, severe (Grade 4) 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

Primary outcomes:
measure: Change of Baseline Tear Breakup Time (TBUT)
timeFrame: 10 weeks
Secondary outcomes:
measure: Change From Baseline Ocular Surface Disease Index (OSDI)
timeFrame: 10 weeks
measure: Change From Baseline Eye Dryness Score (EDS)
timeFrame: 10 weeks
Other outcomes:
measure: Qualitative Assessment of Eyelid Appearance
timeFrame: 10 weeks
measure: Meiboscore
timeFrame: 10 weeks
measure: Percentage of Eyes With Normal Tear Break-Up Time (TBUT)
timeFrame: 10 weeks
measure: Percentage of Subjects With Normal Ocular Surface Disease Index (OSDI)
timeFrame: 10 weeks
measure: Incidence of Ocular Adverse Events
timeFrame: 10 weeks
measure: Incidence of Non-ocular Adverse Events
timeFrame: 10 weeks
measure: Incidence of Unanticipated Serious Adverse Events
timeFrame: 10 weeks
measure: Immediate Biomicroscopy
timeFrame: 10 weeks
measure: Pain/Discomfort During Intense Pulsed Light (IPL)
timeFrame: 10 weeks
measure: Pain/Discomfort During Meibomian Gland Expression (MGX)
timeFrame: 10 weeks
Locations:
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
Study officials:
affiliation: Dell Laser Consultants
name: Steven J Dell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toyos Clinic
name: Rolando Toyos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eye Institute of West Florida
name: Neel Desai, MD
role: PRINCIPAL_INVESTIGATOR
References: