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

NCT04795752 | Completed Results FDA Device

• 1 other identifier: 07093
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• Tear Break-Up Time

  Change in Tear Break-Up Time (TBUT) from baseline to month 6

  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.

  6 months

Study Arms (3)

TearCare Group (Study Device) (Baseline to Month 24)

EXPERIMENTAL

TearCare System

Device: TearCare System

Restasis Group (Control) (Baseline to Month 6)

ACTIVE COMPARATOR

Restasis® (0.05% Cyclosporine ophthalmic emulsion).

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.

Device: TearCare System

Interventions

TearCare System DEVICE

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.

Restasis group crossed over to TearCare (Month 6 to Month 12); TearCare Group (Study Device) (Baseline to Month 24)

Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion DRUG

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.

Also known as: Restasis

Restasis Group (Control) (Baseline to Month 6)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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;
• 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.

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (14)

Doctor My Eyes

Scottsdale, Arizona, 85254, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Loh Ophthalmology Associates

Miami, Florida, 33143, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Vantage Eye Care

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pittsburg-Ophthalmology Dept

Pittsburgh, Pennsylvania, 15213, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 40719437 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: VP, Medical and Clinical Affairs
• Organization: Sight Sciences, Inc

jdickerson@sightsciences.com

1-877-266-1144

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: April 28, 2021
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)