TearCare System to Treat Dry Eye Disease

Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03857919

Acronym

OLYMPIA

Enrollment

235

Registered

2019-02-28

Start date

2019-03-03

Completion date

2020-12-18

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Meibomian Gland Dysfunction

Brief summary

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.

Detailed description

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).

Interventions

DEVICETearCare

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.

DEVICELipiFlow

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.

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

Inclusion criteria

Key Inclusion Criteria: * At least 22 years of age * Reports dry eye symptoms within the past 3 months * Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms. * OSDI Score of 23-79 * 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. * 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 Key

Exclusion criteria

* Use of any of the following medications: 1. Restasis 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 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; 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. 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: 1. Office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment; 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 plug placement within 30 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. (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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Tear Break-Up Time (TBUT) From Baseline	1 month	Tear Break-Up Time is the time measured to the first observation of a break in the tear film
Change in Meibomian Gland Secretion Score From Baseline	1 month	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

Secondary

Measure	Time frame	Description
Change in Total Number of Meibomian Glands Yielding Clear Liquid From Baseline	1 month	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.
Change in Conjunctival Staining Score From Baseline	1 month	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.
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline	1 month	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
Change in Eye Dryness Score (EDS) From Baseline	1 month	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.
Change in Total Number of Meibomian Glands Yielding Any Liquid From Baseline	1 month	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.
Change in Symptom Assessment in Dry Eye (SANDE) Scores From Baseline	1 month	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.
Change in Corneal Staining Score From Baseline	1 month	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	115
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.	120
Total	235

Baseline characteristics

Characteristic	TearCare	LipiFlow	Total
Age, Continuous	57 years STANDARD_DEVIATION 14	55 years STANDARD_DEVIATION 14.5	55.9 years STANDARD_DEVIATION 14.4
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants	19 Participants	40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants	101 Participants	195 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Asian	3 Participants	5 Participants	8 Participants
Race (NIH/OMB) Black or African American	4 Participants	5 Participants	9 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	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	104 Participants	109 Participants	213 Participants
Sex: Female, Male Female	86 Participants	83 Participants	169 Participants
Sex: Female, Male Male	29 Participants	37 Participants	66 Participants
Tear Break Up Time	4.5 seconds STANDARD_DEVIATION 1.2	4.5 seconds STANDARD_DEVIATION 1.2	4.5 seconds STANDARD_DEVIATION 1.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	7 / 115	8 / 120
other Total, other adverse events	7 / 115	8 / 120
serious Total, serious adverse events	0 / 115	0 / 120

Outcome results

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 1. \- Toothpaste 2. \- Cloudy 3. \- Clear

Time frame: 1 month