TearCare System to Treat Dry Eye Disease

Launched by SIGHT SCIENCES, INC. · Feb 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the TearCare System for people who suffer from dry eye disease, specifically looking at how well it works compared to another treatment called the LipiFlow Thermal Pulsation System. The goal is to see if the TearCare System can safely and effectively relieve the uncomfortable symptoms of dry eyes, such as irritation and dryness.

To participate in this study, you need to be at least 22 years old and have moderate to severe symptoms of dry eye. Participants typically use artificial tears regularly and have certain test results showing that their tear quality is not ideal. You should be willing to follow the study's rules and be able to communicate in English. If you are currently using other medications for dry eye or have had certain recent treatments or surgeries, you may not be eligible. If you join the trial, you will help researchers learn more about this new treatment option, which could lead to better care for dry eye disease in the future.

Gender

ALL

Eligibility 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.