Study of the TearCare System in Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye

• Registration Number: NCT03588624
• Lead Sponsor: Sight Sciences, Inc.

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.

Study Timeline

• Study First Submitted: 2018-07-03
• Study Start: 2018-07-12
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-17
• Primary Completion: 2018-10-11
• Study Completion: 2018-11-08
• Results First Submitted: 2024-08-21
• Status Verified: 2025-08
• Results First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Results First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion 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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline	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 Outcome Measures

Name	Time	Method
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Month 1	1 month	The Ocular Surface Disease Index (OSDI) questionnaire is a validated questionnaire that consists of 12 questions to assess ocular symptoms, their impact on patient vision-related functioning, and environmental factors triggering the symptoms.; OSDI Scale Dry Eye Grade 12 or less - Normal 13-22 - Mild 23-32 - Moderate 33 or greater - Severe. Scores may range from 0 (best possible), to 100 (worst possible).; Mean change from baseline at Month 1 is the difference between the mean score at Month 1 and at baseline. A negative score represents improvement.
Total Meibomian Gland Secretion Score at 1 Month	1 month	The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions produced by the meibomian glands in the lower eyelids. Fifteen meibomian glands in each of the lower eyelids were gently pressed and the secretions were scored on the scale below. Sum of the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45. A higher number indicates more normal meibomian gland activity.; Score Description of Secretion 0 Nothing; 1. Toothpaste; 2. Cloudy; 3. Clear
Corneal Staining Score at1 Month	1 month	The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the cornea were added to obtain a total score that ranged from 0-15 where 0 indicates no ocular surface damage or dry eye.
Conjunctival Staining Score at 1 Month	1 Month	The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the conjunctiva were added to obtain a total score that ranged from 0-18, where 0 indicates no ocular surface damage or dry eye.

Trial Locations

Locations (3)

Arlington Eye Physicians; 🇺🇸 Arlington Heights, Illinois, United States

Eye Research Institute; 🇺🇸 Newport Beach, California, United States

Kentucky Eye Institute; 🇺🇸 Lexington, Kentucky, United States