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Completed

NCT Number: NCT03006978

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Eye Care, Ltd.

Arlington Heights, Illinois, 60005, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

TearCare

Device

Warm compress

Device

Primary outcomes

  1. Mean Change in Tear Breakup Time From Baseline to Month 1

    Time frame: 4 weeks

    The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. An increase in TBUT represents an improvement.

Secondary outcomes

  1. Mean Change in Meibomian Gland Score From Baseline to Month 1

    Time frame: 1 month

    Using a Korb Meibomian Gland Evaluator (TearScience), the meibomian gland assessment was conducted by evaluating the consistency of the secretions that were observed upon expression of meibomian glands in the nasal, central, and temporal regions of the lower eyelids. The central, consecutive 5 glands in each region were evaluated. The instrument was held at the eyelid margin for 10-15 seconds, and the secretions were graded on a 0-3 scale for each gland (0=no expression; 1=toothpaste; 2=cloudy; and 3=clear), with a 0-45 score range for each eye. The score for each eye of a subject was averaged. The change from baseline in the Meibomian Gland Score is the difference between the mean baseline value and the mean value at Month 1. A higher score represents an improvement.

  2. Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline

    Time frame: 1 Month

    The Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED questionnaire was used to evaluate 4 symptoms (1-dryness, grittiness, or scratchiness, 2-soreness or irritation, 3-burning or watering, 3-eye fatigue) of study subjects. The maximum score is 28 (worst) and the minimum possible is 0 (best). The SPEED survey measures the severity (0-4 scale - each symptom) and frequency (0-3 scale - each symptom) of these DED symptoms. The SPEED score was calculated by adding the total of the frequency and severity scores; a score of greater than or equal to 6 may be an indicator of DED. The reported value is the mean of the change for all subjects. A negative result indicates improvement.

  3. Mean Change in OSDI Score From Baseline to Month 1

    Time frame: 1 Month

    The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.

  4. Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1

    Time frame: 1 Month

    The SANDE instrument is a simple 2-item questionnaire, that focuses on the frequency and the severity of dry eye symptoms with each measured along a visual analog scale. SANDE, because of its simplicity, is often used in routine clinical practice. For the core questions, the frequency and severity scores are multiplied together, and the square root is taken to produce an overall SANDE score from 0 (best possible) to 100 (worst possible). The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.

Sponsors and collaborators

Lead sponsor

Sight Sciences, Inc.

Industry

Registry information

Official study title

A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 30, 2016
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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