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

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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.


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.)
We found this trial at
1
site
Arlington Heights, Illinois 60005
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mi
from
Arlington Heights, IL
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