Status:
COMPLETED
Pilot Study of TearCare System - Long-Term Extension
Lead Sponsor:
Sight Sciences, Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03804502
Start Date
December 17 2018
End Date
May 21 2019
Last Update
October 28 2025
Active Locations (1)
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1
Central Eye Care
Arlington Heights, Illinois, United States, 60005