Using TearCare to treat dry eye disease
Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
This study is testing if the TearCare System can help people with dry eye disease feel better compared to another treatment called LipiFlow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Sight Sciences, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT03857919 on ClinicalTrials.gov |
What this trial studies
This study compares the TearCare System with the LipiFlow Thermal Pulsation System in patients suffering from dry eye disease. The goal is to evaluate the safety and effectiveness of the TearCare System in alleviating the symptoms and signs associated with this condition. Participants will be monitored for their response to treatment, focusing on improvements in dry eye symptoms and tear production. The study aims to provide evidence that could support the use of TearCare as a viable treatment option.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who experience moderate to severe dry eye symptoms and regularly use artificial tears.
Not a fit: Patients who have recently undergone other dry eye treatments or have certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from dry eye disease.
How similar studies have performed: Other studies have shown success with thermal pulsation systems for treating dry eye, but the effectiveness of the TearCare System specifically is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * At least 22 * Subject has dry eye symptoms and uses artificial tears/lubricants regularly * Subject has moderate to severe symptoms based on a dry eye questionnaire * Subject has an abnormal tear break-up time * Subject's eyelid glands secrete a low amount of meibum * Best corrected visual acuity 20/100 or better * Willing and able to comply with protocol * Willing and able to provide consent * English-speaking Key Exclusion Criteria: * Use of medications that treat dry eye disease or that are known to cause ocular dryness. * Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs * Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing. * History of eyelid, conjunctival or corneal surgery within the past year. * Contact lens use within past 2 weeks * Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.
Where this trial is running
Miami, Florida
- Center for Excellence in Eye Care — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Kavita Dhamdhere, MD
- Email: kdhamdhere@sightsciences.com
- Phone: 877-266-1144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.