NCT03588624

Study of the TearCare System in Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study was conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

Detailed description

This was a prospective, single-arm, post-market, exploratory treatment study designed to collect clinical data regarding the safety and effectiveness of the TearCare System. To reduce potential bias in the study, study staff performing the endpoint assessments was independent of the clinician performing the TearCare procedure. In this study, all subjects received the TearCare procedure. The TearCare procedure included an in-office 15 minute treatment session with the TearCare System immediately (i.e. within 3 minutes) followed by manual expression of the meibomian glands using the Express Forceps. Subjects received one in-office TearCare procedure at the baseline visit and then had follow-up visits at 1 week and 1 month. This study was conducted at 3 sites in the United States.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	TearCare	The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.

Timeline

• Start date: 2018-07-12
• Primary completion: 2018-10-11
• Completion: 2018-11-08
• First posted: 2018-07-17
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study