TearCare System to Treat Dry Eye Disease (OLYMPIA)

September 17, 2019 updated by: Sight Sciences, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Center for Excellence in Eye Care
        • Contact:
          • Maria Mugica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Thermal Pulsation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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.
1 month
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.
1 month
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.
1 month
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.
1 month
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.
1 month
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..
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sight Sciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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