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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)."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TearCare | Experimental | Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. |
|
| LipiFlow | Active Comparator | Subjects will have heat and pressure applied to the eyelids for 12 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TearCare | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Use of any of the following medications:
Restasis or Xiidra within 60 days prior to enrollment;
Antihistamines (oral or topical) within 10 days prior to enrollment;
Systemic medication(s) (other than anti-histamines) 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;
Accutane (at any time);
Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment.
NOTE: Use of any of the above medications (with the exception of 1c) is not permitted during the 1 month follow-up period.
Any of the following dry eye treatments:
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. (Subjects must refrain from wearing contact lenses during the 1-month follow-up.)
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.
In the clinical judgement of the investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton swab.
Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, Salzmann's nodules, etc.)
Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis.
Ocular trauma within 3 months prior to enrollment.
Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
Subject is currently using Retin A or Latisse.
Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
Subject is currently using Lash Boost.
Allergies to silicone tissue adhesives
Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study.
Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol. For example, subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Dickerson, PhD | Sight Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Harvard Eye Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36065356 | Derived | Holland EJ, Loh J, Bloomenstein M, Thompson V, Wirta D, Dhamdhere K. A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease. Clin Ophthalmol. 2022 Aug 30;16:2861-2871. doi: 10.2147/OPTH.S368319. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TearCare | Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: 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. |
| FG001 | LipiFlow | Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TearCare | Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Primary Analysis Population | Posted | Mean | Standard Deviation | Seconds | 1 month |
|
1 Month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TearCare | Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tommie Rodriguez, Senior Clinical Research Manager | Sight Sciences | 18186873310 | trodriguez@sightsciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Jan 31, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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|
| LipiFlow | Device | 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. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 1 month |
| Laguna Hills |
| California |
| 92653 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Loh Ophthalmology Associates | Miami | Florida | 33143 | United States |
| Jackson Eye | Lake Villa | Illinois | 60046 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Kentucky Eye Institute | Lexington | Kentucky | 40517 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| BG001 | LipiFlow | Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Tear Break Up Time | 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. | Mean | Standard Deviation | seconds |
|
Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: 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. |
|
|
| Primary | 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
| Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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 | Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | Number of meibomian glands | 1 month |
|
|
|
| Secondary | 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. | Primary Analysis Population | Posted | Mean | Standard Deviation | Number of meibomian glands | 1 month |
|
|
|
| 7 |
| 115 |
| 0 |
| 115 |
| 7 |
| 115 |
| EG001 | LipiFlow | Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: 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. | 8 | 120 | 0 | 120 | 8 | 120 |
| Superficial Punctate Keratitis (SPK) | Eye disorders | Systematic Assessment |
|
| Decrease in BCVA | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Conjunctival Injection | Eye disorders | Systematic Assessment |
|
| Iritis | Eye disorders | Systematic Assessment |
|
| Epiphora | Eye disorders | Systematic Assessment |
|
| Foreign Body Sensation | Eye disorders | Systematic Assessment |
|
| Ocular Pain | Eye disorders | Systematic Assessment |
|
| Corneal Abrasion | Eye disorders | Systematic Assessment |
|
| Dry Eye Disease | Eye disorders | Systematic Assessment |
|
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