Dry Eye, Meibomian Gland Dysfunction
Conditions
Brief summary
To demonstrate the safety and effectiveness of TearCare® procedures compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients.
Detailed description
In this prospective, multicenter, randomized, active-controlled trial, TearCare is compared to cyclosporine 0.05% ophthalmic emulsion (Restasis) in eyes with dry eye disease (DED). Subjects randomized to TearCare receive TearCare treatment at baseline and Month 5, while subjects randomized to Restasis dose twice-daily with Restasis from baseline through Month 6. Primary inference is based on outcomes at the Month 6 visit including the co-primary endpoints tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI).
Interventions
DEVICETearCare System
TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months.
DRUGCyclosporine Ophthalmic 0.05% Ophthalmic Emulsion
Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At the Month 6 visit subjects will stop Restasis and receive a single TearCare treatment.
Sponsors
Sight Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized parallel group through Month 6 (primary endpoint); TearCare arm continue follow-up through Month 24 to assess durability of treatment; Restasis arm stops Restasis at Month 6 and receives a single TearCare treatment then followed for an additional 6 months through Month 12. Extension portions for both arms are non-comparative.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 22 years of age * Reports dry eye symptoms within the past 3 to 6 months * Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms. * Schirmer tear test (with anesthesia) ≥1 to ≤10 mm in 5 minutes * OSDI Score of 23-79 * TBUT of ≥1 to ≤7 seconds in both eyes * Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye. * At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. * Best corrected visual acuity of 20/100 or better in both eyes. * Willing and able to comply with the study procedures and follow-up * Willing and able to provide informed consent * English-speaking
Exclusion criteria
* Use of any of the following medications: 1. Cyclosporine (Restasis, Cequa etc.) or Xiidra within 60 days prior to enrollment; 2. Antihistamines (oral or topical) within 10 days prior to enrollment; 3. Systemic medication(s) (other than antihistamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial; 4. Accutane (at any time); 5. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or 6. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti- inflammatory medications within 30 days prior to enrollment. * Any of the following dry eye treatments: 1. Office-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \[Lipiflow\], iLux etc.) within 12 months prior to enrollment either as part of routine care or clinical investigation; 2. Meibomian gland expression within 6 months prior to enrollment; 3. Blephex or debridement within 3 months prior to enrollment is an exclusion; 4. Punctal occlusion or punctal plugs. Investigators can choose to remove the punctal plugs 15 days prior to enrollment; 5. Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or 6. Any history of meibomian gland probing * History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery. * Contact lens use within the past 2 weeks. * History of Ocular Herpes Simplex or Ocular Herpes Zoster * Any active, clinically significant ocular or peri-ocular infection or inflammation * Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment * Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. * Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis). * Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-Up Time | 6 months | Change in Tear Break-Up Time (TBUT) from baseline to month 6 |
| OSDI Score | 6 months | Change in Ocular Surface Disease Index (OSDI) score from baseline to 6-months. The 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 6 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 Group (Study Device) TearCare System
TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. | 172 |
| TearCare Group (Study Device) TearCare System
TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. | 344 |
| Restasis Group (Control) Restasis® (0.05% Cyclosporine ophthalmic emulsion
Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. | 173 |
| Restasis Group (Control) Restasis® (0.05% Cyclosporine ophthalmic emulsion
Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. | 346 |
| Total | 1,035 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Primary Endpoint Phase | Lost to Follow-up | 3 | 2 |
| Primary Endpoint Phase | Other | 4 | 1 |
| Primary Endpoint Phase | Physician Decision | 2 | 0 |
| Primary Endpoint Phase | Protocol Violation | 1 | 0 |
| Primary Endpoint Phase | Withdrawal by Subject | 7 | 7 |
| X-over-Restasis arm; Durability-TC arm | Death | 1 | 0 |
| X-over-Restasis arm; Durability-TC arm | Lost to Follow-up | 7 | 0 |
| X-over-Restasis arm; Durability-TC arm | Other | 3 | 1 |
| X-over-Restasis arm; Durability-TC arm | Physician Decision | 1 | 0 |
| X-over-Restasis arm; Durability-TC arm | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | TearCare Group (Study Device) | Restasis Group (Control) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 118 Participants | 59 Participants | 59 Participants |
| Age, Categorical Between 18 and 65 years | 227 Participants | 113 Participants | 114 Participants |
| Age, Continuous | 56.2 years STANDARD_DEVIATION 14 | 55.5 years STANDARD_DEVIATION 14.8 | 56.8 years STANDARD_DEVIATION 13.1 |
| OSDI | 50.0 units on a scale STANDARD_DEVIATION 14.9 | 50.0 units on a scale STANDARD_DEVIATION 14.9 | 50.0 units on a scale STANDARD_DEVIATION 14.9 |
| Race/Ethnicity, Customized Subject Demographics Asian | 16 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized Subject Demographics Black/African American | 18 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Subject Demographics Other/mixed | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Subject Demographics White/Caucasian | 306 Participants | 155 Participants | 151 Participants |
| Region of Enrollment United States | 345 participants | 172 participants | 173 participants |
| Sex: Female, Male Female | 248 Participants | 120 Participants | 128 Participants |
| Sex: Female, Male Male | 97 Participants | 52 Participants | 45 Participants |
| Tear Break Up Time | 4.38 seconds STANDARD_DEVIATION 1.21 | 4.39 seconds STANDARD_DEVIATION 1.26 | 4.37 seconds STANDARD_DEVIATION 1.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 172 | 0 / 173 | 0 / 163 |
| other Total, other adverse events | 23 / 172 | 15 / 173 | 8 / 163 |
| serious Total, serious adverse events | 2 / 172 | 0 / 173 | 0 / 163 |
Outcome results
Primary
OSDI Score
Change in Ocular Surface Disease Index (OSDI) score from baseline to 6-months. The 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 6 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: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TearCare Group (Study Device) | OSDI Score | -18.25 score on a scale | Standard Error 17.98 |
| Restasis Group (Control) | OSDI Score | -15.53 score on a scale | Standard Error 19.86 |
Primary
Tear Break-Up Time
Change in Tear Break-Up Time (TBUT) from baseline to month 6
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TearCare Group (Study Device) | Tear Break-Up Time | 2.71 seconds | Standard Deviation 3.35 |
| Restasis Group (Control) | Tear Break-Up Time | 1.22 seconds | Standard Deviation 2.46 |