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)

Dry Eye Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795752
• Other study ID #: 07093
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: May 22, 2024

Study information

• Verified date: September 2022
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: May 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Device:
• 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. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category.

Drug:
• Restasis
Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure.

Locations

Country	Name	City	State
United States	Vantage Eye Care	Bala-Cynwyd	Pennsylvania
United States	Vision Institute	Colorado Springs	Colorado
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Scripps Health	La Jolla	California
United States	Harvard Eye Associates	Laguna Hills	California
United States	Jackson Eye	Lake Villa	Illinois
United States	Kentucky Eye Institute	Lexington	Kentucky
United States	Loh Ophthalmology Associates	Miami	Florida
United States	Eye Research Foundation	Newport Beach	California
United States	University of Pittsburg-Ophthalmology Dept	Pittsburgh	Pennsylvania
United States	Parkhurst NuVision	San Antonio	Texas
United States	Doctor My Eyes	Scottsdale	Arizona
United States	Vita Eye Clinic	Shelby	North Carolina
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break-Up Time	Mean Change from baseline in Tear Break-Up Time (TBUT)	6 months
Primary	OSDI Score	Mean Change from baseline in OSDI score	6 months