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)
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| ClinicalTrials.gov Identifier: NCT04795752 |
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Recruitment Status :
Recruiting
First Posted : March 12, 2021
Last Update Posted : May 7, 2021
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Sponsor:
Sight Sciences, Inc.
Information provided by (Responsible Party):
Sight Sciences, Inc.
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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 disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Meibomian Gland Dysfunction | Device: TearCare System Drug: Restasis | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | April 23, 2021 |
| Estimated Primary Completion Date : | March 22, 2024 |
| Estimated Study Completion Date : | May 22, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eye Diseases
Drug Information available for:
Cyclosporine
| Arm | Intervention/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. |
Primary Outcome Measures :
- Tear Break-Up Time [ Time Frame: 6 months ]Mean Change from baseline in Tear Break-Up Time (TBUT)
- OSDI Score [ Time Frame: 6 months ]Mean Change from baseline in OSDI score
Information from the National Library of Medicine
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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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.
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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;
- Blephex or debridement within 3 months prior to enrollment is an exclusion;
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795752
Contacts
| Contact: Kavita Dhamdhere, MD | 877-266-1144 | kdhamdhere@sightsciences.com |
Locations
| United States, Arizona | |
| Doctor My Eyes | Recruiting |
| Scottsdale, Arizona, United States, 85254 | |
| United States, California | |
| Scripps Health | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| Harvard Eye Associates | Not yet recruiting |
| Laguna Hills, California, United States, 92653 | |
| Eye Research Foundation | Not yet recruiting |
| Newport Beach, California, United States, 92663 | |
| United States, Colorado | |
| Vision Institute | Not yet recruiting |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Florida | |
| Loh Ophthalmology Associates | Not yet recruiting |
| Miami, Florida, United States, 33143 | |
| United States, Illinois | |
| Jackson Eye | Recruiting |
| Lake Villa, Illinois, United States, 60046 | |
| United States, Kentucky | |
| Cincinnati Eye Institute | Recruiting |
| Edgewood, Kentucky, United States, 41017 | |
| Kentucky Eye Institute | Not yet recruiting |
| Lexington, Kentucky, United States, 40517 | |
| United States, North Carolina | |
| Vita Eye Clinic | Not yet recruiting |
| Shelby, North Carolina, United States, 28150 | |
| United States, Pennsylvania | |
| Vantage Eye Care | Not yet recruiting |
| Bala-Cynwyd, Pennsylvania, United States, 19004 | |
| University of Pittsburg-Ophthalmology Dept | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Dakota | |
| Vance Thompson Vision | Recruiting |
| Sioux Falls, South Dakota, United States, 57108 | |
| United States, Texas | |
| Parkhurst NuVision | Recruiting |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Sight Sciences, Inc.
| Responsible Party: | Sight Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT04795752 |
| Other Study ID Numbers: |
07093 |
| First Posted: | March 12, 2021 Key Record Dates |
| Last Update Posted: | May 7, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Meibomian Gland Dysfunction Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Eyelid Diseases Cyclosporine |
Cyclosporins Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |