NCT03804502

Pilot Study of TearCare System - Long-Term Extension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.

Detailed description

This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study (NCT03006978). In the initial study, subjects with dry eye disease (DED) were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	TearCare	The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-05-21
• Completion: 2019-05-21
• First posted: 2019-01-15
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study