N/A
Completed N=24
A Pilot Study of the TearCare System in Adults With Dry Eye Disease
Source: ClinicalTrials.gov NCT03006978 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Mean Change in Tear Breakup Time From Baseline to Month 1 — 11.7; -0.3 seconds — p=<0.0001
Summary
This is a small, pilot study intended to determine the feasibility of this product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Tear Breakup Time From Baseline to Month 1 |
11.7; -0.3 | <0.0001 sig |
| SECONDARY Mean Change in Meibomian Gland Score From Baseline to Month 1 |
34.7; -0.8 | <0.0001 sig |
| SECONDARY Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline |
-7.9; -1.8 | <0.0001 sig |
| SECONDARY Mean Change in OSDI Score From Baseline to Month 1 |
-25.3; -8.4 | <0.0001 sig |
| SECONDARY Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1 |
-24.6; 2.8 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- At Least 18 Years of age
- Reports dry eye symptoms within 3 months of the screening exam with a SPEED score >=6
- Schirmer 1 value of <10 mm in at least one eye or a Tear Breakup time <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 (NCT03006978). 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. Informational only — not medical advice.