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.
The primary objective of this study was to demonstrate the safety and effectiveness of a single TearCare System treatment compared to a single LipiFlow treatment in relieving the signs and symptoms of dry eye disease. This study was conducted to collect data to support a modification to the TearCare indication for use to read as follows, "The TearCare® System is indicated for the treatment of the signs and symptoms of dry eye disease (DED)."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
235
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.
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.
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Harvard Eye Associates
Laguna Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
Change in Tear Break-Up Time (TBUT) From Baseline
Tear Break-Up Time is the time measured to the first observation of a break in the tear film
Time frame: 1 month
Change in Meibomian Gland Secretion Score From Baseline
The Meibomian Gland Secretion Score grades the consistency of secretions from the meibomian glands. Fifteen meibomian glands in each of the lower eyelids were gently pressed and the secretions were scored on the scale below. Sum of the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45. A higher number indicates more normal meibomian gland activity. Score Description of Secretion: 0 - Nothing 1. \- Toothpaste 2. \- Cloudy 3. \- Clear
Time frame: 1 month
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline
The Ocular Surface Disease Index (OSDI) questionnaire is a validated questionnaire that consists of 12 questions to assess ocular symptoms, their impact on patient vision-related functioning, and environmental factors triggering the symptoms. Scale range is zero (best possible score) to 100 (worst possible score). Mean change is the average of the difference between Month 1 and baseline for each subject. A negative result represents improvement. OSDI Scale Dry Eye Grade 12 or less - Normal 13-22 - Mild 23-32 - Moderate 33 or greater - Severe
Time frame: 1 month
Change in Corneal Staining Score From Baseline
The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the cornea were added to obtain a total score that ranged from 0-15 where 0 indicates no ocular surface damage or dry eye.
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Loh Ophthalmology Associates
Miami, Florida, United States
Jackson Eye
Lake Villa, Illinois, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Kentucky Eye Institute
Lexington, Kentucky, United States
Ophthalmology Associates
St Louis, Missouri, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Parkhurst NuVision
San Antonio, Texas, United States
Time frame: 1 month
Change in Conjunctival Staining Score From Baseline
The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the conjunctiva were added to obtain a total score that ranged from 0-18, where 0 indicates no ocular surface damage or dry eye.
Time frame: 1 month
Change in Symptom Assessment in Dry Eye (SANDE) Scores From Baseline
The SANDE instrument is a simple 2-item questionnaire, that focuses on the frequency and the severity of dry eye symptoms with each measured along a visual analog scale. SANDE, because of its simplicity, is often used in routine clinical practice. For the core questions, the frequency and severity scores are multiplied together, and the square root is taken to produce an overall SANDE score from 0 (best possible) to 100 (worst possible). The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.
Time frame: 1 month
Change in Eye Dryness Score (EDS) From Baseline
Severity of dry eye symptoms assessed on a 100 mm visual analog scale (VAS) ranging from 'Never/Very comfortable' to 'All the time/Very severe' and scored from 0 to 100: "0" = no discomfort/very comfortable, "100" = very severe.
Time frame: 1 month
Change in Total Number of Meibomian Glands Yielding Clear Liquid From Baseline
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
Change in Total Number of Meibomian Glands Yielding Any Liquid From Baseline
This is a count of the number of glands scored as having any secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.
Time frame: 1 month