NCT03006978

A Pilot Study of the TearCare System in Adults With Dry Eye Disease

A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a small, pilot study intended to determine the feasibility of this product.

Detailed description

The objective of this study was to evaluate the safety and effectiveness of the TearCare® System in adult patients with clinically significant dry eye disease (DED). This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects with DED were randomized to either a single TearCare treatment conducted at the clinic or 4 weeks of daily warm compress (WC) therapy. The TearCare procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual expression of the meibomian glands. WC therapy consisted of once daily application of the compresses to the eyelids for 5 minutes. Subjects were followed until 6 months post-treatment.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	TearCare
DEVICE	Warm Compress

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-02-01
• Completion: 2018-03-01
• First posted: 2016-12-30
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study