Efficiency and Changes of Cytokines Expression in Tear After Intense Pulsed Light Treating Dry Eye Disease

NCT04165785 | Completed FDA Device

• 1 other identifier: 198302
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to investigate changes of tear cytokines levels as well as the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients with meibomian gland dysfunction-Associated demodicosis. The effect of OPT IPL will be examined in a study designed as a randomised controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of OPT IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the OPT IPL pulses will be disabled. For each subject, the duration of the study will be 2 months , as explained in the detailed description.

Conditions

Dry Eye Syndromes

Keywords

Optimal pulsed technology intense pulsed light; meibomian gland dysfunction; demodicosis; Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• change of baseline demodex counts

  Six lashes with cylindrical dandruff (CD) were epilated from each eye (3 in upper eyelid and 3 in lower eyelid) under slit lamp and mounted on glass slides and were examined under optical microscopy to confirm the presence of D folliculorum. Demodex counts greater than or equal to 1 were Demodex-positive.

  2 months

• change of baseline tear cytokines levels

  Change of IL-1α, IL-1β, IL-6, IL-7, IL-12p40, IL-13, IL-17A, IL-8, MMP-3, MMP-9 in the study eye, from baseline to follow-up, in both eyes

  2 months

Secondary Outcomes (7)

• Change from baseline of Ocular Surface Disease Index score

  2 months

• change from baseline of schirmer I test

  2 months

• change from baseline of the Lid margin abnormalities score

  2 months

• change from baseline of meibum grade score

  2 months

• change from baseline of corneal fluorescein staining score

  2 months

Study Arms (2)

OPT IPL followed by MGX

EXPERIMENTAL

Subjects in the experimental arm will receive OPT IPL followed by MGX: OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Interventions: Device: IPL Procedure: MGX

Device: OPT IPL; Procedure: MGX

Sham OPT IPL followed by MGX

SHAM COMPARATOR

Subjects in the sham comparator arm will receive Sham OPT IPL followed by MGX: Sham OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Interventions: Device: Sham IPL Procedure: MGX

Device: Sham OPT IPL; Procedure: MGX

Interventions

OPT IPL DEVICE

Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

OPT IPL followed by MGX

Sham OPT IPL DEVICE

Sham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

Sham OPT IPL followed by MGX

MGX PROCEDURE

Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side.

OPT IPL followed by MGX; Sham OPT IPL followed by MGX

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to read, understand and sign an Informed Consent (IC) form
• years of age
• Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
• In the study eye, tear break up time ≤ 7 seconds
• In the study eye, Meibomian Gland Score (MGS) ≤ 12
• In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
• Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) 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
• Subjects 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 560 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 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
• Over exposure to sun, within 4 weeks prior to screening
• Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
• Radiation therapy to the head or neck, within 12 months prior to screening

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

The First affiliated hospital of harbin medical university

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects in the study arm will receive a series of OPT IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with OPT IPL and meibomian gland expression. Subjects in the control arm will be treated with sham OPT IPL and meibomian gland expression.

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 18, 2019
• Study Start: August 20, 2018
• Primary Completion: June 28, 2019
• Study Completion: July 28, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)