NCT02621593

Brief Summary

The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

November 24, 2015

Last Update Submit

February 1, 2017

Conditions

Dry Eye Syndromes

Keywords

Meibomian Gland DysfunctionDry eye symptomsIntense Pulsed Light

Outcome Measures

Primary Outcomes (1)

  • Tear Break-up time in seconds, using the standard Fluorescein staining method

    The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film

    from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment

Secondary Outcomes (5)

  • Corneal fluorescein staining score, using the Baylor Scheme

    from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

  • Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"

    from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

  • Subjective symptoms, using the SPEED questionnaire

    from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

  • Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample

    from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

  • Lipid Layer Thickness in nanometers, using an interferometer

    from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

Other Outcomes (3)

  • Incidence of treatment-related adverse events and serious adverse events

    1 day after baseline; 1 week after baseline ; 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); 9 weeks after baseline (Tx4/FU1); 12 weeks after baseline (FU2); and 15 weeks after baseline (FU3)

  • immediate/short term skin response

    At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)

  • Subjective level of pain/discomfort.

    At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)

Study Arms (1)

Treatment of dry eye secondary to MGD

EXPERIMENTAL

Intervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system

Device: M22-IPL

Interventions

M22-IPLDEVICE

The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.

Treatment of dry eye secondary to MGD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read, understand and sign an Informed Consent (IC) form
  • years of age
  • Fitzpatrick skin type 1-4
  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • At least 5 non-atrophied glands on each eye's lower eyelid
  • Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria:
  • Tear break-up time (TBUT) ≤ 10 seconds in both eyes;
  • Meibomian gland (MG) score (using the Abbreviated MGD grading system for clinical trials) ≥ 11 in both eyes
  • Corneal Fluorescein Staining (CFS) score (using the Baylor grading scheme) ≥ 10 in both eyes;
  • Tear Osmolarity ≥ 310 milliosmol/L in both eyes, or a difference higher than 8 milliosmol/L between the two eyes
  • SPEED ≥ 10
  • Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nuvaring and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

You may not qualify if:

  • Contact lens wearer within the past 1 month and throughout the study
  • Recent ocular surgery or eyelid surgery within the past 6 months
  • Neuro-paralysis in the planned treatment area within the past 6 months
  • Other uncontrolled eye disorders affecting the ocular surface
  • 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 who have undergone laser in situ keratomileusis (LASIK) surgery within the past 6 months
  • Diseases in the planned treatment area that could be stimulated by light at 560 nm to 1200 nm (e.g., Herpes simplex 1 and 2, Systemic Lupus erythematosus, porphyria)
  • Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, or St. John's Wort
  • Over exposure to sun within the past 4 weeks, in the judgment of the treating physician
  • Pregnancy and nursing
  • Administration of prescription eye drops for dry eye within the past 48 hours, excluding artificial tears
  • Radiation therapy to the head or neck within the past year, or planned radiation therapy within 8 weeks after completion of all IPL treatments
  • Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy within 8 weeks after completion of all IPL treatments
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaster Eye Center

Beverly Hills, California, 90211, United States

Location

Dell Laser Consultants

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • Steven Dell, MD

    Medical Director, Dell LAser Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 3, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

US(2)