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Trial record 3 of 2528 for:    sight sciences

TearCare System to Treat Dry Eye Disease (OLYMPIA)

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ClinicalTrials.gov Identifier: NCT03857919
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Sight Sciences, Inc.

Brief Summary:

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.


Condition or disease Intervention/treatment Phase
Dry Eye Meibomian Gland Dysfunction Device: TearCare Device: LipiFlow Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
Actual Study Start Date : March 3, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: TearCare
Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
Device: TearCare
The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.

Active Comparator: LipiFlow
Subjects will have heat and pressure applied to the eyelids for 12 minutes.
Device: LipiFlow
The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Other Name: Thermal Pulsation




Primary Outcome Measures :
  1. Tear Break-Up Time [ Time Frame: 1 month ]
    Tear Break-Up Time is the time measured to the first observation of a break in the tear film

  2. Meibomian Gland Secretion Score [ Time Frame: 1 month ]
    The Meibomian Gland Secretion score is the measure of the quality of the secretions in the meibomian glands. Secretions are scored on a scale from 0-3, with 0 indicating no secretion and 3 indicating clear secretions. Fifteen glands are scored in each lower eyelid. Total score ranges from 0-45.


Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: 1 month ]
    The OSDI is a questionnaire that measures the severity of symptoms of dry eye disease. Total score can range from 0-100. A score of 0-12 is normal, 13-22 is mild, 23-32 is moderate, and 33-100 is severe dry eye.

  2. Corneal staining score [ Time Frame: 1 month ]
    This scores the amount of staining observed on the surface of the cornea using the NEI Scale. Five regions of the cornea are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-15.

  3. Conjunctival staining score [ Time Frame: 1 month ]
    This scores the amount of staining observed on the surface of the conjunctiva using the NEI scale. Six regions of the conjunctiva are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-18.

  4. SANDE [ Time Frame: 1 month ]
    Symptom Assessment iN Dry Eye (SANDE) questionnaire is a visual analog scale the measures the severity and frequency of dry eye symptoms. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst.

  5. Eye Dryness Score [ Time Frame: 1 month ]
    Eye Dryness Score is a visual analog scale the measures the level of discomfort related to eye dryness. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst.

  6. Meibomian glands yielding clear secretions [ Time Frame: 1 month ]
    This is a count of the number of glands scored as having clear secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.

  7. Meibomian glands yielding clear or cloudy secretions [ Time Frame: 1 month ]
    This is a count of the glands scored as having clear or cloudy secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best..



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • At least 22
  • Subject has dry eye symptoms and uses artificial tears/lubricants regularly
  • Subject has moderate to severe symptoms based on a dry eye questionnaire
  • Subject has an abnormal tear break-up time
  • Subject's eyelid glands secrete a low amount of meibum
  • Best corrected visual acuity 20/100 or better
  • Willing and able to comply with protocol
  • Willing and able to provide consent
  • English-speaking

Key Exclusion Criteria:

  • Use of medications that treat dry eye disease or that are known to cause ocular dryness.
  • Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
  • Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
  • History of eyelid, conjunctival or corneal surgery within the past year.
  • Contact lens use within past 2 weeks
  • Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

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): NCT03857919


Contacts
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Contact: Anne-Marie Ripley 877-266-1144 anne@sightsciences.com

Locations
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United States, Florida
Center for Excellence in Eye Care Recruiting
Miami, Florida, United States, 33176
Contact: Anne Ripley         
Sponsors and Collaborators
Sight Sciences, Inc.

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Responsible Party: Sight Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03857919     History of Changes
Other Study ID Numbers: 06196
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases