TearCare System to Treat Dry Eye Disease
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 3/7/2019 |
| Start Date: | March 2019 |
| End Date: | October 2019 |
| Contact: | Anne-Marie Ripley |
| Email: | anne@sightsciences.com |
| Phone: | 877-266-1144 |
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
In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation
System in patients with dry eye disease. The objective is to demonstrate that the TearCare
System is safe and effective in relieving the signs and symptoms of dry eye disease.
NOTE: All sites have been selected for this study. We are not seeking additional sites at
this time.
System in patients with dry eye disease. The objective is to demonstrate that the TearCare
System is safe and effective in relieving the signs and symptoms of dry eye disease.
NOTE: All sites have been selected for this study. We are not seeking additional sites at
this time.
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.
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