TearCare System to Treat Dry Eye Disease (OLYMPIA)
Primary Purpose
Dry Eye, Meibomian Gland Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TearCare
LipiFlow
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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.
Sites / Locations
- Center for Excellence in Eye CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TearCare
LipiFlow
Arm Description
Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
Subjects will have heat and pressure applied to the eyelids for 12 minutes.
Outcomes
Primary Outcome Measures
Tear Break-Up Time
Tear Break-Up Time is the time measured to the first observation of a break in the tear film
Meibomian Gland Secretion Score
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
Ocular Surface Disease Index (OSDI)
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.
Corneal staining score
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.
Conjunctival staining score
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.
SANDE
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.
Eye Dryness Score
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.
Meibomian glands yielding clear secretions
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.
Meibomian glands yielding clear or cloudy secretions
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..
Full Information
NCT ID
NCT03857919
First Posted
February 26, 2019
Last Updated
September 17, 2019
Sponsor
Sight Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03857919
Brief Title
TearCare System to Treat Dry Eye Disease
Acronym
OLYMPIA
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sight Sciences, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TearCare
Arm Type
Experimental
Arm Description
Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
Arm Title
LipiFlow
Arm Type
Active Comparator
Arm Description
Subjects will have heat and pressure applied to the eyelids for 12 minutes.
Intervention Type
Device
Intervention Name(s)
TearCare
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LipiFlow
Other Intervention Name(s)
Thermal Pulsation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tear Break-Up Time
Description
Tear Break-Up Time is the time measured to the first observation of a break in the tear film
Time Frame
1 month
Title
Meibomian Gland Secretion Score
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
1 month
Title
Corneal staining score
Description
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.
Time Frame
1 month
Title
Conjunctival staining score
Description
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.
Time Frame
1 month
Title
SANDE
Description
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.
Time Frame
1 month
Title
Eye Dryness Score
Description
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.
Time Frame
1 month
Title
Meibomian glands yielding clear secretions
Description
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.
Time Frame
1 month
Title
Meibomian glands yielding clear or cloudy secretions
Description
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..
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kavita Dhamdhere, MD
Phone
877-266-1144
Email
kdhamdhere@sightsciences.com
Facility Information:
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Mugica
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36065356
Citation
Holland EJ, Loh J, Bloomenstein M, Thompson V, Wirta D, Dhamdhere K. A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease. Clin Ophthalmol. 2022 Aug 30;16:2861-2871. doi: 10.2147/OPTH.S368319. eCollection 2022.
Results Reference
derived
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TearCare System to Treat Dry Eye Disease
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