Status:
COMPLETED
Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
Lead Sponsor:
Lumenis Be Ltd.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
22-85 years
Phase:
NA
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 exam...
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 interva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03396913
Start Date
January 10 2018
End Date
August 15 2019
Last Update
December 9 2020
Active Locations (2)
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1
Toyos Clinic
Nashville, Tennessee, United States, 37215
2
Dell Laser Consultants
Austin, Texas, United States, 78746