Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Not Applicable

Completed

Conditions: Dry Eye Syndrome

Interventions: Device: Sham IPL
Device: IPL
Procedure: MGX

Registration Number: NCT03396913

Lead Sponsor: Lumenis Be Ltd.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPL followed by Meibomian Gland Expression (MGX)	MGX	Subjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Sham IPL followed by MGX	MGX	Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Sham IPL followed by MGX	Sham IPL	Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
IPL followed by Meibomian Gland Expression (MGX)	IPL	Subjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes.

Primary Outcome Measures

Name	Time	Method
Change of Baseline Tear Breakup Time (TBUT)	10 weeks	Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Ocular Surface Disease Index (OSDI)	10 weeks	Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up. OSDI was collected per patient (one number per patient). The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye.
Change From Baseline Eye Dryness Score (EDS)	10 weeks	Change of self-assessed symptoms on a visual analog scale (VAS) , from baseline to follow-up, in both eyes. Values were collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. VAS scores are not validated for dry eye. Hence, it is not known how to correlate VAS values to severity levels of dry eye. However, one can make estimations from the literature of VAS in other conditions. For example, in patients with chronic musculoskeletal pain, in a VAS scale of 0 to 10 scores below 3.4 corresponded to mild pain, scores between 3.5 and 7.4 corresponded to moderate pain, and scores above 7.5 corresponded to severe pain. Using such results from other conditions, it is \estimated\ that values between 0 and 34 correspond to mild symptoms, scores between 35 and 74 correspond to moderate symptoms, and scores above 75 correspond to severe symptoms.