Clinical trial NCT06349356: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"
Official title: " Prospective Evaluation of Efficacy and Safety of C.STIM® , an Intense Pulsed Light Device to Treat Signs and Symptoms of Dry Eye Disease (DED)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Quantel Medical
Sponsor class: INDUSTRY
First posted: 2024-04-05
Enrollment: 101
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:

• 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).


Eligibility criteria: Inclusion Criteria:

* Patient is able to read, understand and sign an information consent and image right forms
* 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:

* 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
* 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

Primary outcomes:
measure: Tear Break-Up Time evolution
timeFrame: 60 days
Secondary outcomes:
measure: dry eye signs and symptoms
timeFrame: 60 days
measure: dry eye signs and symptoms
timeFrame: 60 days
measure: dry eye signs and symptoms
timeFrame: 60 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 60 days
measure: Meibum quality
timeFrame: 60 days
measure: Meibum Expressibility
timeFrame: 60 days
measure: Use of artificial tear drops
timeFrame: 60 days
measure: Use of artificial tear drops
timeFrame: 60 days
measure: Glaucoma
timeFrame: 60 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Visionary Consultants Inc.
state: Kentucky
city: Raleigh
country: United States
facility: Triangle Eye Consultants
state: North Carolina
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Kenosha
country: United States
facility: Eye Centers of Racine & Kenosha
state: Wisconsin
Study officials:
References: