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Dry EyeOLYMPIANCT03857919

TearCare System to Treat Dry Eye Disease

A study testing TearCare and LipiFlow in people with Dry Eye and Meibomian Gland Dysfunction, run by Sight Sciences, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Dry Eye, Meibomian Gland Dysfunction
What is being tested?
TearCare and LipiFlow
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
10 sitesUnited States
Study dates
3 Mar 2019to 18 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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:
  • Office-based dry eye treatment (e.g. IPL, thermal pulsation [Lipiflow], etc.) within 12 months prior to enrollment;
  • Meibomian gland expression within 6 months prior to enrollment;
  • Blephex or debridement within 3 months prior to enrollment is an exclusion;
  • Punctal occlusion or punctal plug placement within 30 days prior to enrollment;
  • Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • Harvard Eye Associates

    Laguna Hills, California, 92653

  • Jackson Eye

    Lake Villa, Illinois, 60046

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517

  • Loh Ophthalmology Associates

    Miami, Florida, 33143

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Parkhurst NuVision

    San Antonio, Texas, 78229

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

  • Ophthalmology Associates

    St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: 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

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.

Read the 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)."

Being tested
TearCare, LipiFlow
Medical subject headings
Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TearCareDevice

    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.

  • LipiFlowDevice

    Also called Thermal Pulsation

    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 groups in NCT03857919
Study groupRoleWhat they receive
TearCareExperimentalSubjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
Receives: Device: TearCare
LipiFlowActive comparatorSubjects will have heat and pressure applied to the eyelids for 12 minutes.
Receives: Device: LipiFlow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

  2. 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

    Measured: 1 month

Secondary outcomes (7)

  1. 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

    Measured: 1 month

  2. 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.

    Measured: 1 month

  3. 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.

    Measured: 1 month

  4. 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.

    Measured: 1 month

  5. 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.

    Measured: 1 month

  6. 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.

    Measured: 1 month

  7. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start3 Mar 2019
  3. Primary completion17 Feb 2020
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857919
Sponsor's protocol ID
06196
Acronym
OLYMPIA
Status last verified
Aug 2025
First submitted
26 Feb 2019
Last updated
1 Oct 2025
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36065356

Questions about this trial

What is this clinical trial studying?

A study testing TearCare and LipiFlow in people with Dry Eye and Meibomian Gland Dysfunction, run by Sight Sciences, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tear Break-Up Time (TBUT) From Baseline (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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