Dry Eye Syndromes
Conditions
Brief summary
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage 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 and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage. NOTE: All sites have been selected for this study.
Detailed description
This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months. All subjects will complete an informed consent form indicating their voluntary participation in the study. Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.
Interventions
DEVICETearCare
TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
DEVICEWarm Compress and Lid Massage
Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.
Sponsors
Sight Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with dry eye disease * Signs and symptoms of dry eye disease * Best corrected visual acuity 20/100 or better * Willing and able to comply with study procedures * Willing and able to provide consent
Exclusion criteria
* Active ocular infection or inflammation * History of eyelid, conjunctiva or corneal surgery within the past year. * Recent office-based dry eye treatment, punctal occlusion or punctal plug placement * Contact lens wearer * Significant ocular surface or eyelid abnormalities, recent ocular trauma * Certain corneal surface abnormalities * Use of medications for treatment of dry eye or medications that cause dry eye * Systemic disease that results in dry eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Tear Break-Up Time From Baseline to Month 1 | 1 month | The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in OSDI Score From Baseline to Month 1 | 1 month | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TearCare TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.
TearCare: TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands. | 7 |
| Warm Compress & Lid Massage Subjects will perform warm compress and lid massage at home daily.
Warm Compress and Lid Massage: Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | TearCare | Warm Compress & Lid Massage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 10.1 | 55.9 years STANDARD_DEVIATION 20.9 | 62.45 years STANDARD_DEVIATION 18.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
| Tear Break Up Time | 4.9 seconds STANDARD_DEVIATION 0.8 | 4.7 seconds STANDARD_DEVIATION 0.7 | 4.8 seconds STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Mean Change in Tear Break-Up Time From Baseline to Month 1
The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TearCare | Mean Change in Tear Break-Up Time From Baseline to Month 1 | 1.4 seconds | Standard Deviation 2.3 |
| Warm Compress & Lid Massage | Mean Change in Tear Break-Up Time From Baseline to Month 1 | 2.5 seconds | Standard Deviation 2.8 |
Secondary
Mean Change in OSDI Score From Baseline to Month 1
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TearCare | Mean Change in OSDI Score From Baseline to Month 1 | -13.7 units on a scale | Standard Deviation 12.5 |
| Warm Compress & Lid Massage | Mean Change in OSDI Score From Baseline to Month 1 | -10.0 units on a scale | Standard Deviation 7.7 |