Dry EyeNCT04795752
Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)
A study testing TearCare System and Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion in people with Dry Eye and Meibomian Gland Dysfunction, run by Sight Sciences, Inc. at 14 sites in United States.
Trial 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. 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 System and Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 14 sitesUnited States
- Study dates
- 28 Apr 2021to 23 Sep 2024
- 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 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
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- 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
Who cannot join
- Use of any of the following medications:
- Cyclosporine (Restasis, Cequa etc.) or Xiidra within 60 days prior to enrollment;
- Antihistamines (oral or topical) within 10 days prior to enrollment;
- 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;
- Accutane (at any time);
- Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
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- 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:
- 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;
- 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 plugs. Investigators can choose to remove the punctal plugs 15 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.
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Vantage Eye Care
Bala-Cynwyd, Pennsylvania, 19004
Vision Institute
Colorado Springs, Colorado, 80907
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Scripps Health
La Jolla, California, 92037
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
University of Pittsburg-Ophthalmology Dept
Pittsburgh, Pennsylvania, 15213
Parkhurst NuVision
San Antonio, Texas, 78229
Doctor My Eyes
Scottsdale, Arizona, 85254
Vita Eye Clinic
Shelby, North Carolina, 28150
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: 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.
Read the 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).
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Being tested
- TearCare System, Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion
- 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.
TearCare SystemDevice
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.
Cyclosporine Ophthalmic 0.05% Ophthalmic EmulsionDrug
Also called Restasis
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.
| Study group | Role | What they receive |
|---|---|---|
| TearCare Group (Study Device) (Baseline to Month 24) | Experimental | TearCare System Receives: Device: TearCare System |
| Restasis Group (Control) (Baseline to Month 6) | Active comparator | Restasis® (0.05% Cyclosporine ophthalmic emulsion). Receives: Drug: Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion |
| Restasis group crossed over to TearCare (Month 6 to Month 12) | Experimental | 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. Receives: Device: TearCare System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-Up Time
Change in Tear Break-Up Time (TBUT) from baseline to month 6
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start28 Apr 2021
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Dickerson, PhD, Study director, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795752
- Sponsor's protocol ID
- 07093
- Status last verified
- Nov 2025
- First submitted
- 9 Mar 2021
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hovanesian J, Ayres BD, Bloomenstein MR, Loh J, Chester T, Saenz B, Echegoyen J, Kannarr SR, Rodriguez TC, Dickerson JE Jr. Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial. Optom Vis Sci. 2025 Aug 1;102(8):495-504. doi: 10.1097/OPX.0000000000002278. Epub 2025 Jul 25.
PubMed 40719437
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04795752
- Acronym / sponsor ID
- 07093
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| TearCare Group (Study Device) (Baseline to Month 24) | Experimental | Device: TearCare SystemTearCare System |
| Restasis Group (Control) (Baseline to Month 6) | Active comparator | Drug: Cyclosporine Ophthalmic 0.05% Ophthalmic EmulsionRestasis® (0.05% Cyclosporine ophthalmic emulsion). |
| Restasis group crossed over to TearCare (Month 6 to Month 12) | Experimental | Device: TearCare SystemSubjects 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (22 listed)
- Use of any of the following medications:
- 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.
- History of Ocular Herpes Simplex or Ocular Herpes Zoster
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TearCare SystemTearCare 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. | Device | Restasis group crossed over to TearCare (Month 6 to Month 12), TearCare Group (Study Device) (Baseline to Month 24) |
| Cyclosporine Ophthalmic 0.05% Ophthalmic EmulsionAlso: RestasisRestasis 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. | Drug | Restasis Group (Control) (Baseline to Month 6) |
Primary outcome
Tear Break-Up Time
Time frame: 6 months
Change in Tear Break-Up Time (TBUT) from baseline to month 6
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40719437Hovanesian J, Ayres BD, Bloomenstein MR, Loh J, Chester T, Saenz B, Echegoyen J, Kannarr SR, Rodriguez TC, Dickerson JE Jr. Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial. Optom Vis Sci. 2025 Aug 1;102(8):495-504. doi: 10.1097/OPX.0000000000002278. Epub 2025 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Dickerson, PhD study director
Sight Sciences, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TearCare System and Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion in people with Dry Eye and Meibomian Gland Dysfunction, run by Sight Sciences, Inc. at 14 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 12 inclusion and 22 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 24 Nov 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?
Tear Break-Up Time (time frame: 6 months). 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 NCT04795752, 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 24 Nov 2025.