A Pilot Study of the TearCare System in Adults With Dry Eye Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-03-31

Brief Summary

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This is a small, pilot study intended to determine the feasibility of this product.

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Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TearCare

Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands. This procedure will be performed at the Baseline visit.

Group Type EXPERIMENTAL

TearCare

Intervention Type DEVICE

Warm Compress

Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.

Group Type ACTIVE_COMPARATOR

Warm Compress

Intervention Type DEVICE

Interventions

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TearCare

Intervention Type DEVICE

Warm Compress

Intervention Type DEVICE

Eligibility Criteria

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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).
* 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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No