Expired Study
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Arlington Heights, Illinois 60005


Purpose:

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.


Criteria:

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.)


NCT ID:

NCT03804502


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Arlington Heights, Illinois 60005
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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