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

NCT06349356 | Completed FDA Device

• 2 other identifiers: FDACSTIM0012023IRB00000533
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (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).

  60 days

Secondary Outcomes (9)

• dry eye signs and symptoms

  60 days

• dry eye signs and symptoms

  60 days

• dry eye signs and symptoms

  60 days

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  60 days

• Meibum quality

  60 days

Study Arms (2)

Intense Pulsed Light treated arm

EXPERIMENTAL

The treatment consists in Intense Pulsed Light C.STIM® with recommended fluence.

Device: Intense pulsed light with C.STIM device

Very low fluence Intense Pulsed Light arm (placebo)

PLACEBO COMPARATOR

The treatment consists in Intense Pulsed Light C.STIM® with a very low fluence.

Device: Intense pulsed light with C.STIM device

Interventions

Intense pulsed light with C.STIM device DEVICE

4 flashes per treatment session

Intense Pulsed Light treated arm; Very low fluence Intense Pulsed Light arm (placebo)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quantel Medical: lead

Study Sites (4)

Visionary Consultants Inc.

Lexington, Kentucky, 40517, United States

Location

Triangle Eye Consultants

Raleigh, North Carolina, 27617, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 5, 2024
• Study Start: March 28, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)