Pilot Study of TearCare System - Long-Term Extension
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/17/2019 |
Start Date: | December 17, 2018 |
End Date: | July 2019 |
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.
effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye
syndrome who had previously been treated with the TearCare System.
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.)
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