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)

Not Applicable

Active, not recruiting

• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Interventions: Device: TearCare System; Drug: Restasis

• Registration Number: NCT04795752
• Lead Sponsor: Sight Sciences, Inc.

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

Not available

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-04-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13
• Primary Completion: 2024-03-22
• Study Completion: 2024-05-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TearCare Group (Study Device)	TearCare System	-
Restasis Group (Control)	Restasis	-

Primary Outcome Measures

Name	Time	Method
OSDI Score	6 months	Mean Change from baseline in OSDI score
Tear Break-Up Time	6 months	Mean Change from baseline in Tear Break-Up Time (TBUT)

Trial Locations

Locations (14)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Doctor My Eyes; 🇺🇸 Scottsdale, Arizona, United States

Scripps Health; 🇺🇸 La Jolla, California, United States

Vision Institute; 🇺🇸 Colorado Springs, Colorado, United States

Jackson Eye; 🇺🇸 Lake Villa, Illinois, United States

Cincinnati Eye Institute; 🇺🇸 Edgewood, Kentucky, United States

Loh Ophthalmology Associates; 🇺🇸 Miami, Florida, 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