TearCare© Demonstrates Superiority Over Leading Dry Eye Prescription in Landmark 2-Year SAHARA RCT

Clinical evidence for a new order of care

SAHARA Randomized Controlled Trial (RCT)

24-month, prospective, randomized, masked, multicenter (19 sites), controlled trial to evaluate the safety and effectiveness of the Tearcare® System vs. Restasis® in the treatment of the signs and symptoms of dry eye disease.1-3

SAHARA RCT Design

High Standard of Evidence

Levels of Evidence for Therapeutic Studies — Centre for Evidence- Based Medicine, http://www.cebm.net.
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Stage I Stage II Stage III
Stage I: Head to Head

TearCare® is Clinically Superior to Restasis®1

Superior improvements in TBUT and MGSS1

Significant improvements in signs and symptoms*1

* At 6 months TearCare® and Restasis® both demonstrated comparable statistically significant improvements at all time points measured for corneal and conjunctival staining, tear production, and OSDI scores. TearCare® was noninferior to Restasis® in OSDI/Corneal Staining.

* Symptoms were statistically significant vs. baseline at every time point.
Stage II: Crossover

Additional Improvements in Signs and Symptoms by Switching to TearCare®2

Additional improvements in signs and symptoms of dry eye when patients discontinued Restasis® and crossed over to TearCare®2

Additional improvements not reliant on patient adherence2

Stage III: Durability

2 TearCare® Therapies in the First 5 Months Provides 2 Years of Relief after First Therapy Session for Most Patients†3

Significant Improvements in TBUT and MGSS sustained over 2 years with TearCare®3

Improvements in signs and symptoms sustained over 2 years with TearCare3

† 66% of TearCare® patients experienced dry eye relief for up to 2 years from study baseline.

At Sight Sciences, we believe patients should have insured access to interventional 
MGD therapy – and doctors should be fairly reimbursed for delivering it.

Today, only 5% of patients receive thermal expression therapy, even though 86% may need it.4,5 That’s why we’re investing in change. The two-year SAHARA RCT represents a significant investment and a clear commitment to building the clinical foundation required to drive insurance coverage and fair reimbursement for TearCare® and the patients it serves.
Together We Can Achieve Fair Access for All
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Eligibility Criteria

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

Exclusion Criteria:

  • 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.
  • Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).

Abbreviations: TBUT – Tear Breakup Time, MGSS – Meibomian Gland Secretion Score, OSDI – Ocular Surface Disease Index, DED – Dry Eye Disease, MGD – Meibomian Gland Disease.

References:

  1. Ayres BD, et al. Clin Ophthalmol. 2023 Dec 18;17:3925-3940.
  2. Ayres BD, et al. Clin Ophthalmol. 2024 May 28;18:1525-1534.
  3. 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.
    Optometry and Vision Science. (Published ahead of print) 2025;102: doi: 10.1097/OPX.0000000000002278
  4. Market Scope 2021 Ocular Surface Disease Survey.
  5. Lemp MA, et al. Cornea. 2012 May;31(5):472-478.

 
For additional information and to access the full study publications please use the reference titles above.
 
TearCare® System – Patient Important Safety Information

Indications for Use: The TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands. Potential adverse events associated with the use of the TearCare® System include swelling, redness or discomfort of eyelids, allergic reaction to medical adhesive, temporary visual disturbance such as blurry vision, foreign body sensation, stye, or blocked oil glands, temporary worsening of dryness in the eye. Please talk to your doctor for complete risk information, and to discuss whether the TearCare® System is right for you.


The TEARCARE Clearance Assistant™ is indicated to express meibum from meibomian glands.
TearCare, SmartLids, SmartHub, and Clearance Assistant, are trademarks or registered trademarks of Sight Sciences, Inc.
All other trademarks are the property of their respective owners.

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