COMPLETED

Study of the TearCare System in Dry Eye Disease

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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

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.

Official Title

Study of the TearCare System in Dry Eye Disease

Quick Facts

Study Start:2018-07-12

Study Completion:2018-11-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03588624

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:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 22 years of age 2. Reports dry eye symptoms within the past 3 months 3. Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms. 4. OSDI Score of ≥23 5. TBUT of ≤7 seconds in both eyes 6. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye. 7. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. 8. Best spectacle corrected visual acuity of 20/100 or better in both eyes. 9. Willing and able to comply with the study procedures and follow-up 10. Willing and able to provide informed consent 11. English-speaking	1. Any active, clinically significant ocular or peri-ocular infection or inflammation 2. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment 3. 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. 4. 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. 5. Meibomian gland expression within 6 months prior to enrollment. In addition, any history of meibomian gland probing is an exclusion. 6. 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. 7. Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.) 8. Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.) 9. History of Ocular Herpes Simplex or Ocular Herpes Zoster 10. Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.) 11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, distichiasis, trichiasis) 12. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. 13. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area 14. Ocular trauma within 3 months prior to enrollment 15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis 16. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation 17. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea 18. Punctal occlusion or punctal plug placement within 30 days prior to enrollment 19. Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) 20. Allergies to silicone tissue adhesives 21. Use of Restasis or Xiidra within 60 days prior to enrollment. Subject must also be willing to remain off these drugs for the duration of the study. 22. Use of antihistamines (oral or topical) within 10 days prior to enrollment. Subject must also be willing remain off antihistamines for the duration of the study. 23. Subject is currently on a 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. 24. Subject has taken or is currently taking Accutane 25. Subject requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within 30 days prior to enrollment 26. Subject is currently using Retin A or Latisse 27. 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. 28. 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. Subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

Inclusion Criteria

Exclusion Criteria

1. At least 22 years of age
2. Reports dry eye symptoms within the past 3 months
3. Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
4. OSDI Score of ≥23
5. TBUT of ≤7 seconds in both eyes
6. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye.
7. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
8. Best spectacle corrected visual acuity of 20/100 or better in both eyes.
9. Willing and able to comply with the study procedures and follow-up
10. Willing and able to provide informed consent
11. English-speaking

1. Any active, clinically significant ocular or peri-ocular infection or inflammation
2. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
3. 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.
4. 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.
5. Meibomian gland expression within 6 months prior to enrollment. In addition, any history of meibomian gland probing is an exclusion.
6. 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.
7. Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.)
8. Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.)
9. History of Ocular Herpes Simplex or Ocular Herpes Zoster
10. Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.)
11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, distichiasis, trichiasis)
12. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
13. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area
14. Ocular trauma within 3 months prior to enrollment
15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis
16. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
17. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
18. Punctal occlusion or punctal plug placement within 30 days prior to enrollment
19. Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
20. Allergies to silicone tissue adhesives
21. Use of Restasis or Xiidra within 60 days prior to enrollment. Subject must also be willing to remain off these drugs for the duration of the study.
22. Use of antihistamines (oral or topical) within 10 days prior to enrollment. Subject must also be willing remain off antihistamines for the duration of the study.
23. Subject is currently on a 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.
24. Subject has taken or is currently taking Accutane
25. Subject requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within 30 days prior to enrollment
26. Subject is currently using Retin A or Latisse
27. 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.
28. 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. Subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

Contacts and Locations

Principal Investigator

Jaime C Dickerson, PhD

STUDY_DIRECTOR

Sight Sciences

Study Locations (Sites)

Eye Research Institute

Newport Beach, California, 92663

United States

Arlington Eye Physicians

Arlington Heights, Illinois, 60005

United States

Kentucky Eye Institute

Lexington, Kentucky, 40517

United States

Collaborators and Investigators

Sponsor: Sight Sciences, Inc.

Jaime C 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 Date2018-07-12

Study Completion Date2018-11-08

Study Record Updates

Study Start Date2018-07-12

Study Completion Date2018-11-08

Terms related to this study

Additional Relevant MeSH Terms

Dry Eye