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

NCT ID: NCT04795752

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2024-09-23

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

TearCare System

Group Type: EXPERIMENTAL

TearCare System

Intervention Type: 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 (Control) (Baseline to Month 6)

Restasis® (0.05% Cyclosporine ophthalmic emulsion).

Group Type: ACTIVE_COMPARATOR

Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

TearCare System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Restasis

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.

• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime Dickerson, PhD

Role: STUDY_DIRECTOR

Sight Sciences, Inc.

Locations

Doctor My Eyes

Scottsdale, Arizona, United States

Scripps Health

La Jolla, California, United States

Harvard Eye Associates

Laguna Hills, California, United States

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Loh Ophthalmology Associates

Miami, Florida, United States

Jackson Eye

Lake Villa, Illinois, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

Vita Eye Clinic

Shelby, North Carolina, United States

Vantage Eye Care

Bala-Cynwyd, Pennsylvania, United States

University of Pittsburg-Ophthalmology Dept

Pittsburgh, Pennsylvania, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Parkhurst NuVision

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40719437 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

07093

Identifier Type: -

Identifier Source: org_study_id