COMPLETED

TearCare System to Treat Dry Eye Disease

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

Official Title

Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease

Quick Facts

Study Start:2019-03-03

Study Completion:2020-12-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03857919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 23-79 * TBUT of ≤7 seconds in both eyes * Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye. * At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. * Best 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 * English-speaking	* Use of any of the following medications: 1. Restasis or Xiidra within 60 days prior to enrollment; 2. Antihistamines (oral or topical) within 10 days prior to enrollment; 3. Systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial; 4. Accutane (at any time); 5. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or 6. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment. * Any of the following dry eye treatments: 1. Office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment; 2. Meibomian gland expression within 6 months prior to enrollment; 3. Blephex or debridement within 3 months prior to enrollment is an exclusion; 4. Punctal occlusion or punctal plug placement within 30 days prior to enrollment; 5. Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or 6. Any history of meibomian gland probing * 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. * Contact lens use within the past 2 weeks. (Subjects must refrain from wearing contact lenses during the 1-month follow-up.) * History of Ocular Herpes Simplex or Ocular Herpes Zoster * 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 * Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. * Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis). * Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area. * 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. * Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, Salzmann's nodules, etc.) * Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea * Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis. * Ocular trauma within 3 months prior to enrollment. * Known history of diminished or abnormal facial, periocular, ocular or corneal sensation * Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) * Subject is currently using Retin A or Latisse. * Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes. * Subject is currently using Lash Boost. * Allergies to silicone tissue adhesives * Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study. * Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol. For example, subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

Inclusion Criteria

Exclusion 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 23-79
* TBUT of ≤7 seconds in both eyes
* Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
* At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
* Best 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
* English-speaking

* Use of any of the following medications:
1. Restasis or Xiidra within 60 days prior to enrollment;
2. Antihistamines (oral or topical) within 10 days prior to enrollment;
3. Systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
4. Accutane (at any time);
5. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
6. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment.
* Any of the following dry eye treatments:
1. Office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment;
2. Meibomian gland expression within 6 months prior to enrollment;
3. Blephex or debridement within 3 months prior to enrollment is an exclusion;
4. Punctal occlusion or punctal plug placement within 30 days prior to enrollment;
5. Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or
6. Any history of meibomian gland probing
* 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.
* Contact lens use within the past 2 weeks. (Subjects must refrain from wearing contact lenses during the 1-month follow-up.)
* History of Ocular Herpes Simplex or Ocular Herpes Zoster
* 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
* Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
* Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
* Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
* 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.
* Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, Salzmann's nodules, etc.)
* Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
* Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis.
* Ocular trauma within 3 months prior to enrollment.
* Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
* Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
* Subject is currently using Retin A or Latisse.
* Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
* Subject is currently using Lash Boost.
* Allergies to silicone tissue adhesives
* Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study.
* Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol. For example, subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

Contacts and Locations

Principal Investigator

Jaime Dickerson, PhD

STUDY_DIRECTOR

Sight Sciences

Study Locations (Sites)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260

United States

Harvard Eye Associates

Laguna Hills, California, 92653

United States

Eye Research Foundation

Newport Beach, California, 92663

United States

Loh Ophthalmology Associates

Miami, Florida, 33143

United States

Jackson Eye

Lake Villa, Illinois, 60046

United States

Cincinnati Eye Institute

Edgewood, Kentucky, 41017

United States

Kentucky Eye Institute

Lexington, Kentucky, 40517

United States

Ophthalmology Associates

St Louis, Missouri, 63131

United States

Vance Thompson Vision

Sioux Falls, South Dakota, 57108

United States

Parkhurst NuVision

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Sight Sciences, Inc.

Jaime Dickerson, PhD, STUDY_DIRECTOR, Sight Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-03

Study Completion Date2020-12-18

Study Record Updates

Study Start Date2019-03-03

Study Completion Date2020-12-18

Terms related to this study

Additional Relevant MeSH Terms

Dry Eye
Meibomian Gland Dysfunction