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Tear Film Innovations iLux Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055897
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tear Film Innovations, Inc.

Brief Summary:
Measure the change in the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Device: iLux 2020 System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tear Film Innovations iLux Safety Study
Actual Study Start Date : May 3, 2016
Actual Primary Completion Date : May 17, 2016
Actual Study Completion Date : May 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: iLux 2020 System
Meibomian Gland Heating
Device: iLux 2020 System
Application of heat to the meibomian glands to determine potential impact on eyes and surrounding tissue.




Primary Outcome Measures :
  1. Corneal and surrounding eye lid tissue temperature [ Time Frame: 1 hour ]
    Change from baseline to post-procedure


Other Outcome Measures:
  1. Incidence of adverse events (%) [ Time Frame: 1 hour ]
  2. Incidence of discomfort/pain based on study questionnaire (scale 1-10) [ Time Frame: 1 hour ]
  3. Incidence of ocular surface staining [ Time Frame: 1 hour ]
  4. Incidence of clinically significant changes in keratometry (diopter) [ Time Frame: 1 hour ]
  5. Incidence of clinically significant changes in manifest refraction (diopter) [ Time Frame: 1 hour ]
  6. Incidence of clinically significant changes in BSCVA (# of letters) [ Time Frame: 1 hour ]
  7. Incidence of clinically significant changes in intraocular pressure (mm Hg) [ Time Frame: 1 hour ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years and older of any gender or race
  2. Provision of subject written informed consent prior to study participation

Exclusion Criteria:

  1. History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
  2. Ocular trauma or herpetic keratitis within the previous 3 months
  3. Cicatricial lid margin disease identified via slit lamp examination
  4. Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
  5. Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis keratitis)
  6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy
  7. Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
  8. Grade 3 or 4 meibomianitis, and/or blepharitis on a scale of 0 to 4
  9. Women who are pregnant, nursing, or not utilizing adequate birth control measures
  10. Individuals using another investigational device or agent within 30 days of study participation
  11. Body temperature above 37°C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055897


Locations
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United States, California
Encinitas Optometry
Encinitas, California, United States, 92924
Sponsors and Collaborators
Tear Film Innovations, Inc.
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Responsible Party: Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier: NCT03055897    
Other Study ID Numbers: 2020-02
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: Yes
Product Manufactured in and Exported from the U.S.: No