Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

November 10, 2025 updated by: Sight Sciences, Inc.

Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Doctor My Eyes
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Vision Institute
    • Florida
      • Miami, Florida, United States, 33143
        • Loh Ophthalmology Associates
    • Illinois
      • Lake Villa, Illinois, United States, 60046
        • Jackson Eye
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute
      • Lexington, Kentucky, United States, 40517
        • Kentucky Eye Institute
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Vita Eye Clinic
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Vantage Eye Care
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburg-Ophthalmology Dept
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision
    • Texas
      • San Antonio, Texas, United States, 78229
        • Parkhurst NuVision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TearCare Group (Study Device) (Baseline to Month 24)
TearCare System
Device: 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.
Active Comparator: Restasis Group (Control) (Baseline to Month 6)
Restasis® (0.05% Cyclosporine ophthalmic emulsion).
Drug: Cyclosporine 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.
Other Names:
  • Restasis
Experimental: Restasis group crossed over to TearCare (Month 6 to Month 12)
Subjects originally randomized to Restasis stop Restasis use at Month 6 and receive a single TearCare treatment at Month 6 and are then followed through Month 12.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tear Break-Up Time
Time Frame: 6 months
Change in Tear Break-Up Time (TBUT) from baseline to month 6
6 months
OSDI Score
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sight Sciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jaime Dickerson, PhD, Sight Sciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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