Study of the TearCare System in Dry Eye Disease
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|ClinicalTrials.gov Identifier: NCT03588624|
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 17, 2018
This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.
NOTE: All sites have been selected for this study.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Device: TearCare||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the TearCare System in Dry Eye Disease|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
All subjects in the study will undergo the TearCare procedure one time at the baseline visit. They will then be followed out to one month.
The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.
- Change in Tear Break-up time from baseline to 1 month [ Time Frame: 1 month ]Tear Break-up Time is defined as the number of seconds between a blink and the appearance of a first dry spot or negative staining in the tear film.
- Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month [ Time Frame: 1 month ]The OSDI is a questionnaire that assesses the symptoms of dry eye disease
- Change in Meibomian gland secretion score from baseline to 1 month [ Time Frame: 1 month ]The is a measure of the quality of the secretions from the meibomian glands
- Change in Cornea staining score from baseline to 1 month [ Time Frame: 1 month ]This is a measure of the degree of staining on the cornea.
- Change in Conjunctival staining score from baseline to 1 month [ Time Frame: 1 month ]This is a measure of the degree of staining on the conjunctiva
- Device-related adverse events [ Time Frame: 1 month ]Any untoward adverse event that is attributed to the study device
- Change in best spectacle-corrected visual acuity from baseline to 1 month [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588624
|Contact: Anne Ripleyemail@example.com|
|United States, California|
|Eye Research Institute||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Yvette Abbascia 949-650-1863 firstname.lastname@example.org|
|United States, Kentucky|
|Kentucky Eye Institute||Recruiting|
|Lexington, Kentucky, United States, 40517|
|Contact: Justin Tincher email@example.com|