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Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03658811
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Toyos Clinic

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE September 5, 2018
Results First Submitted Date  ICMJE December 6, 2018
Results First Posted Date  ICMJE February 12, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
Non-invasive Tear Break up Time (TBUT) [ Time Frame: 2 weeks ]
average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
Non-invasive tear break up time [ Time Frame: 2 weeks ]
average of 3 measurements using fluorescein dye and stopwatch to monitor first sign of tear film break up
Change History Complete list of historical versions of study NCT03658811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Measure of Visual Analog Scale Pain Over Last 24 Hours [ Time Frame: 24 hours ]
    measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)
  • Ocular Discomfort Frequency Assessment on Visual Analog Scale [ Time Frame: 24 hours ]
    scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes
  • Measure of Visual Analog Scale Pain [ Time Frame: 2 weeks ]
    measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • Measure of Visual Analog Scale Pain Over Last 24 Hours [ Time Frame: 24 hours ]
    measure of pain on scale of minimum of 0(no pain)- maximum of 100 (maximal pain and worse outcome)
  • Ocular Discomfort Frequency Assessment on Visual Analog Scale [ Time Frame: 24 hours ]
    scale of minimum of 0(no episodes)-maximum of 100 (constant painful episodes and worse outcome) frequency of dry eye pain episodes
  • Measure of Visual Analog Scale Pain [ Time Frame: 2 weeks ]
    measure of pain since last visit on scale of minimum of 0 (no pain)- maximum of 100 (maximal pain and worse outcome)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease
Official Title  ICMJE Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease
Brief Summary Upper eyelid treatment has not been used with previously described methods of treatment of dry eye disease using intense pulsed light therapy because the upper lids disease was typically not as advanced as lower lid and because direct treatment of the upper lid was not felt to be necessary as each light pulse extended over the entire periorbita even when concentrated on the lower lid.
Detailed Description Dry eye disease is an under-diagnosed and growing problem. Intense pulsed light has been a proven method of improving the signs and symptoms of meibomian gland dysfunction including lid margin vascularity, meibum viscosity, OSDI mean score and tear break up. This study looks at the safety and effect of treatment of upper lids only to evaluate the safety and efficacy of direct upper lid treatment on the signs and symptoms of dry eye.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Patient were enrolled in the study if they had visible signs of upper lid meibomian gland dysfunction and persistent dry eye symptoms and pain despite treatment with conservative dry eye therapies.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE Device: intense pulsed light
Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Study Arms  ICMJE Experimental: Upper eyelid meibomian gland dysfunction
Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments
Intervention: Device: intense pulsed light
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2018)
20
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subjects older than 18
  • cloudy or inspissated meibomian glands in both upper lids
  • ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride.

Exclusion Criteria:

  • Patients with eyelid abnormalities
  • intense pulsed light treatment within the past year.
  • Patients on oral retinoids,
  • patients undergoing intraocular surgery within the past year,
  • patients with uncontrolled ocular disease,
  • Fitzpatrick skin type V or VI,
  • neuro-paralysis in the planned treatment area in the past 6 months,
  • pre-cancerous lesions in the planned treatment area.
  • New topical eye treatments,
  • previous expression of meibomian glands,
  • legally blind in one eye.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03658811
Other Study ID Numbers  ICMJE TCLum-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Excel spreadsheet with data but no identifying characteristics could be shared.
Responsible Party Toyos Clinic
Study Sponsor  ICMJE Toyos Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Toyos Clinic
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP