A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Sight Sciences, Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Mean Change in Tear Breakup Time From Baseline to Month 1
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This is a small, pilot study intended to determine the feasibility of this product.
Detailed Description
The objective of this study was to evaluate the safety and effectiveness of the TearCare® System in adult patients with clinically significant dry eye disease (DED). This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects with DED were randomized to either a single TearCare treatment conducted at the clinic or 4 weeks of daily warm compress (WC) therapy. The TearCare procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual expression of the meibomian glands. WC therapy consisted of once daily application of the compresses to the eyelids for 5 minutes. Subjects were followed until 6 months post-treatment.
Investigators
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).
Outcomes
Primary Outcomes
Mean Change in Tear Breakup Time From Baseline to Month 1
Time Frame: 4 weeks
The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. An increase in TBUT represents an improvement.
Secondary Outcomes
- Mean Change in Meibomian Gland Score From Baseline to Month 1(1 month)
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline(1 Month)
- Mean Change in OSDI Score From Baseline to Month 1(1 Month)
- Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1(1 Month)