Pilot Study of TearCare System - Long-Term Extension

Not Applicable

• Conditions: Dry Eye Syndromes
• Interventions: Device: TearCare

• Registration Number: NCT03804502
• Lead Sponsor: Sight Sciences, Inc.

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

Not available

Study Timeline

• Study Start: 2018-12-17
• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TearCare	TearCare	Subjects will receive one TearCare treatment at the baseline visit

Primary Outcome Measures

Name	Time	Method
Tear Break-Up Time	1 month	Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 month	All device-related and ocular adverse events will be collected.
Conjunctival staining	1 month	This measures the degree of staining on the surface of the conjunctival using the NEI scale.
Meibomian Gland Secretion Score	1 month	This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.
SPEED II Questionnaire	1 month	The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.
Corneal staining	1 month	This measures the degree of staining on the surface of the cornea using the NEI scale.
OSDI Questionnaire	1 month	The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.

Trial Locations

Locations (1)

Central Eye Care; 🇺🇸 Arlington Heights, Illinois, United States