Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"

" Prospective Evaluation of Efficacy and Safety of C.STIM® , an Intense Pulsed Light Device to Treat Signs and Symptoms of Dry Eye Disease (DED)"

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: Intense pulsed light with C.STIM device

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Visionary Consultants Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • Triangle Eye Consultants
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Eye Centers of Racine & Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intense Pulsed Light treated arm; The treatment consists in Intense Pulsed Light C.STIM® with recommended fluence.	Device: Intense pulsed light with C.STIM device; 4 flashes per treatment session
Placebo Comparator: Very low fluence Intense Pulsed Light arm (placebo); The treatment consists in Intense Pulsed Light C.STIM® with a very low fluence.	Device: Intense pulsed light with C.STIM device; 4 flashes per treatment session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Break-Up Time evolution	Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dry eye signs and symptoms	Evolution of dry eye signs and symptoms: DEQ5, Dry Eye Questionnaire 5, score varies from 0 (normal) to 22 (severe symptoms).	60 days
dry eye signs and symptoms	Evolution of dry eye signs and symptoms: NIBUT, Non Invasive Break Up Time, normal if higher than 10 second.	60 days
dry eye signs and symptoms	Evolution of dry eye signs and symptoms: OSDI, the Ocular Surface Disease Index is a questionnaire with score from 0 (normal) to 100 (severe dry eye symptoms)	60 days
Meibum quality	Quality of meibum evaluation by Meibomian gland secretion assessment using Meibum Quality : : is assessed in each of 8 glands of the central third of the lower lid on a 0-3 scale for each gland: 0=clear meibum / 1=cloudy meibum/ 2=cloudy with debris (granular)/3=thick, like toothpaste	60 days
Meibum Expressibility	Quality of meibum evaluation by Meibomian gland secretion assessment using Meibum Expressibility : Expressibility of meibum is assessed from 5 glands: 0= all glands expressible / 1=3-4 glands expressible/ 2= 1-2 glands expressible./ 3=no glands expressible.	60 days
Use of artificial tear drops	Change in use of artificial tear drops frequency before treatment and after treatment	60 days
Use of artificial tear drops	Change in use of artificial tear drops quantity before treatment and after treatment	60 days
Glaucoma	Observation of the difference in evolution of dry eye disease in glaucoma vs non-glaucoma patients : comparaison of the Tear Break Up Time in second (normal if superior to 10 seconds)	60 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Assessment of device safety and tolerability (ocular and dermatologic aspect) : comparison of number of adverse event occurence between the two arms	60 days

Collaborators and Investigators

• Sponsor: Quantel Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): July 11, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: FDACSTIM0012023; IRB00000533 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No