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Dry Eye DiseaseNCT06349356

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

A study testing Intense pulsed light with C.STIM device in people with Dry Eye Disease, run by Quantel Medical at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
Intense pulsed light with C.STIM device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
4 sitesUnited States
Study dates
28 Mar 2023to 11 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Eye Centers of Racine & Kenosha

    Kenosha, Wisconsin, 53142

  • Visionary Consultants Inc.

    Lexington, Kentucky, 40517

  • Toyos Clinic

    Nashville, Tennessee, 37215

  • Triangle Eye Consultants

    Raleigh, North Carolina, 27617

Other trials in United States

About this study

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)"

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).

Conditions
Dry Eye Disease
Being tested
Intense pulsed light with C.STIM device
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intense pulsed light with C.STIM deviceDevice

    4 flashes per treatment session

Study groups in NCT06349356
Study groupRoleWhat they receive
Intense Pulsed Light treated armExperimentalThe treatment consists in Intense Pulsed Light C.STIM® with recommended fluence.
Receives: Device: Intense pulsed light with C.STIM device
Very low fluence Intense Pulsed Light arm (placebo)Placebo comparatorThe treatment consists in Intense Pulsed Light C.STIM® with a very low fluence.
Receives: Device: Intense pulsed light with C.STIM device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 60 days

Secondary outcomes (9)

  1. 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).

    Measured: 60 days

  2. dry eye signs and symptoms

    Evolution of dry eye signs and symptoms: NIBUT, Non Invasive Break Up Time, normal if higher than 10 second.

    Measured: 60 days

  3. 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)

    Measured: 60 days

  4. 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

    Measured: 60 days

  5. 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

    Measured: 60 days

  6. 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.

    Measured: 60 days

  7. Use of artificial tear drops

    Change in use of artificial tear drops frequency before treatment and after treatment

    Measured: 60 days

  8. Use of artificial tear drops

    Change in use of artificial tear drops quantity before treatment and after treatment

    Measured: 60 days

  9. 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)

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start28 Mar 2023
  3. Primary completion11 Jul 2024
  4. Study completion11 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349356
Sponsor's protocol ID
FDACSTIM0012023
Other IDs
IRB00000533
Status last verified
May 2024
First submitted
22 Mar 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intense pulsed light with C.STIM device in people with Dry Eye Disease, run by Quantel Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Break-Up Time evolution (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06349356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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