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 : September 18, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
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.
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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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..
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
|Contact: Kavita Dhamdhere, MDfirstname.lastname@example.org|
|United States, Florida|
|Center for Excellence in Eye Care||Recruiting|
|Miami, Florida, United States, 33176|
|Contact: Maria Mugica|