Pilot Study of TearCare System - Long-Term Extension

Sight Sciences

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Device: TearCare

Study type

Interventional

Funder types

Industry

Identifiers

NCT03804502

06215

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)