Pilot Study of TearCare System - Long-Term Extension

NCT ID: NCT03804502

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2019-05-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TearCare

Subjects will receive one TearCare treatment at the baseline visit

Group Type: EXPERIMENTAL

TearCare

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Previously enrolled in the TearCare arm of the TearCare Pilot Study
• Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
• TBUT of <10 seconds in at least one eye
• Willing to comply with the study, procedures, and follow-up
• Willing and able to provide consent

Exclusion Criteria

• Any active ocular or peri-ocular infection or inflammation
• Recurrent eye inflammation within the past 3 months
• Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
• Ocular surface abnormalities that may affect tear film distribution or treatment
• Abnormal eyelid function in either eye
• Diminished or abnormal facial, periocular, ocular or corneal sensation
• Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
• Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
• Allergies to silicone tissue adhesives
• An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
• Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
• Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
• Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
• Participation in another ophthalmic clinical trial within the past 30 days
• Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Badawi, MD

Role: PRINCIPAL_INVESTIGATOR

Sight Sciences, Inc.

Locations

Central Eye Care

Arlington Heights, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

06215

Identifier Type: -

Identifier Source: org_study_id