N/A
N=12
Pilot Study of TearCare System - Long-Term Extension
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03804502 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Mean Change in Tear Break-Up Time From Extension Study Baseline to Month 1 — 12.4 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TearCare (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sight Sciences, Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Tear Break-Up Time From Extension Study Baseline to Month 1 |
12.4 | — |
| SECONDARY Mean Change in Meibomian Gland Score From Extension Study Baseline to Month 1 |
19.5 | — |
| SECONDARY Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1 |
-2.9 | — |
| SECONDARY Mean Change in OSDI Questionnaire Result From Extension Study Baseline to Month 1. |
-11.2 | — |
| SECONDARY Mean Change in Corneal Staining From Extension Study Baseline to Month 1 |
-0.17 | — |
| SECONDARY Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1 |
-0.54 | — |
| SECONDARY Mean Change in SANDE Result From Extension Study Baseline to Month 1 |
-13.2 | — |
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.
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.)
Data sourced from ClinicalTrials.gov (NCT03804502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.