Study of the TearCare System in Dry Eye Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Sight Sciences, Inc.
- Enrollment
- 29
- Locations
- 3
- Primary Endpoint
- Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This study was conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.
Detailed Description
This was a prospective, single-arm, post-market, exploratory treatment study designed to collect clinical data regarding the safety and effectiveness of the TearCare System. To reduce potential bias in the study, study staff performing the endpoint assessments was independent of the clinician performing the TearCare procedure. In this study, all subjects received the TearCare procedure. The TearCare procedure included an in-office 15 minute treatment session with the TearCare System immediately (i.e. within 3 minutes) followed by manual expression of the meibomian glands using the Express Forceps. Subjects received one in-office TearCare procedure at the baseline visit and then had follow-up visits at 1 week and 1 month. This study was conducted at 3 sites in the United States.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 22 years of age
- •Reports dry eye symptoms within the past 3 months
- •Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
- •OSDI Score of ≥23
- •TBUT of ≤7 seconds in both eyes
- •Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye.
- •At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
- •Best spectacle corrected visual acuity of 20/100 or better in both eyes.
- •Willing and able to comply with the study procedures and follow-up
- •Willing and able to provide informed consent
Exclusion Criteria
- •Any active, clinically significant ocular or peri-ocular infection or inflammation
- •Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
- •History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
- •Any office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment. In addition Blephex or debridement within 3 months prior to enrollment is an exclusion.
- •Meibomian gland expression within 6 months prior to enrollment. In addition, any history of meibomian gland probing is an exclusion.
- •In the clinical judgement of the investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton swab.
- •Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.)
- •Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.)
- •History of Ocular Herpes Simplex or Ocular Herpes Zoster
- •Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.)
Outcomes
Primary Outcomes
Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline
Time Frame: 1 month
TBUT is an indicator of tear film instability and measures the length of time it takes for the tear film to break down. An increase in TBUT represents an improvement.
Secondary Outcomes
- Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Month 1(1 month)
- Total Meibomian Gland Secretion Score at 1 Month(1 month)
- Corneal Staining Score at1 Month(1 month)
- Conjunctival Staining Score at 1 Month(1 Month)