Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"
NCT ID: NCT06349356
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2023-03-28
2024-07-11
Brief Summary
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• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).
Researchers will compare treated group and placebo to respond to the main question.
Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intense Pulsed Light treated arm
The treatment consists in Intense Pulsed Light C.STIM® with recommended fluence.
Intense pulsed light with C.STIM device
4 flashes per treatment session
Very low fluence Intense Pulsed Light arm (placebo)
The treatment consists in Intense Pulsed Light C.STIM® with a very low fluence.
Intense pulsed light with C.STIM device
4 flashes per treatment session
Interventions
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Intense pulsed light with C.STIM device
4 flashes per treatment session
Eligibility Criteria
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Inclusion Criteria
* aged over 22 years old
* Fitzpatrick skin type I-IV
* Patient is able and willing to comply with the treatment/FU schedule and requirements
* Meibomian Gland Score : Meibum Quality according to Tear Film and Occular Surface Society recommendation: ≥ 16 for 1 eye and 8 central glands in the lower eyelid
* At least 5 non-atrophied meibomian glands in the lower eyelid
* Tear break-up time (TBUT) ≤ 10 seconds
* Symptoms self-assessed using the Occular Surface Disease Index questionnaire ≥ 23
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
* Patients 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 610 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 610-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
* Over exposure to sun, within 4 weeks prior to screening
* Using of topical drops, only artificial tears and glaucoma treatments are authorized
* 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 (face), or oral therapies, within 3 months prior to screening, analgesics for pain management, oral omega 3 fatty acid supplements are authorized
* 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 Itense Pulsed Light 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 on the EFRON scale) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
* In either eye, severe (Grade 4 on the EFRON scale) 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 and pterigyum)
* 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. Patients must discontinue these medications for at least 1 month prior to the baseline visit.
* Any condition revealed whereby the investigator deems the Patient inappropriate for this study
22 Years
ALL
No
Sponsors
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Quantel Medical
INDUSTRY
Responsible Party
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Locations
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Visionary Consultants Inc.
Lexington, Kentucky, United States
Triangle Eye Consultants
Raleigh, North Carolina, United States
Toyos Clinic
Nashville, Tennessee, United States
Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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IRB00000533
Identifier Type: OTHER
Identifier Source: secondary_id
FDACSTIM0012023
Identifier Type: -
Identifier Source: org_study_id