Pilot Study of TearCare System - Long-Term Extension

Dry Eye Syndromes Clinical Trial

Official title:

Pilot Study of TearCare System - Long-Term Extension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03804502
• Other study ID #: 06215
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: July 2019

Study information

• Verified date: January 2019
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• TearCare
The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.

Locations

Country	Name	City	State
United States	Central Eye Care	Arlington Heights	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break-Up Time	Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.	1 month
Secondary	Meibomian Gland Secretion Score	This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.	1 month
Secondary	SPEED II Questionnaire	The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.	1 month
Secondary	OSDI Questionnaire	The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.	1 month
Secondary	Corneal staining	This measures the degree of staining on the surface of the cornea using the NEI scale.	1 month
Secondary	Conjunctival staining	This measures the degree of staining on the surface of the conjunctival using the NEI scale.	1 month
Secondary	Adverse Events	All device-related and ocular adverse events will be collected.	1 month