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)

Sponsor
Sight Sciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04795752
Collaborator
(none)
300
Enrollment
14
Locations
2
Arms
37
Anticipated Duration (Months)
21.4
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 23, 2021
Anticipated Primary Completion Date :
Mar 22, 2024
Anticipated Study Completion Date :
May 22, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: TearCare Group (Study Device)

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.

Active Comparator: Restasis Group (Control)

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.

Outcome Measures

Primary Outcome Measures

  1. Tear Break-Up Time [6 months]

    Mean Change from baseline in Tear Break-Up Time (TBUT)

  2. OSDI Score [6 months]

    Mean Change from baseline in OSDI score

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Doctor My EyesScottsdaleArizonaUnited States85254
2Scripps HealthLa JollaCaliforniaUnited States92037
3Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
4Eye Research FoundationNewport BeachCaliforniaUnited States92663
5Vision InstituteColorado SpringsColoradoUnited States80907
6Loh Ophthalmology AssociatesMiamiFloridaUnited States33143
7Jackson EyeLake VillaIllinoisUnited States60046
8Cincinnati Eye InstituteEdgewoodKentuckyUnited States41017
9Kentucky Eye InstituteLexingtonKentuckyUnited States40517
10Vita Eye ClinicShelbyNorth CarolinaUnited States28150
11Vantage Eye CareBala-CynwydPennsylvaniaUnited States19004
12University of Pittsburg-Ophthalmology DeptPittsburghPennsylvaniaUnited States15213
13Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
14Parkhurst NuVisionSan AntonioTexasUnited States78229

Sponsors and Collaborators

  • Sight Sciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sight Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT04795752
Other Study ID Numbers:
  • 07093
First Posted:
Mar 12, 2021
Last Update Posted:
May 7, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 7, 2021