iTear Single-center, Open-label, Single-arm Study

NCT06525961 | Not Yet Recruiting Phase 4 FDA Device

• 1 other identifier: itear2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help people with Dry Eye Disease (DED) who are not satisfied with using artificial tears. The study will last three months and take place at one location. Thirty participants will use the iTEAR100 Neurostimulator, which stimulates the outside of the nose to help with dry eye symptoms. Participants will have three main visits: one at the start (Day 0), one after 30 days (Day 30), and one at the end of the study (Day 90). For the first 30 days, they will use the device twice a day for 30 seconds on each side of the nose. After that, they will use it as needed for the next 60 days. Before starting the treatment, participants will undergo tests to measure their initial eye condition. The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90. Participants will also fill out a questionnaire about their eye symptoms on Day 14. The main measure of success is how much the participants' symptoms improve on the Ocular Surface Disease Index (OSDI) from Day 0 to Day 30. Other measures include changes in tear production, tear quality, and eye health from Day 0 to Days 30 and 90. Participants' safety will be monitored by tracking any adverse events (side effects) throughout the study.

Conditions

Dry Eye Disease; Dry Eye Syndromes; Dry Eye; Meibomian Gland Dysfunction

Keywords

Dry Eye; DED; Dry Eye Syndromes; Meibomian Gland Dysfunction (MGD)

Outcome Measures

Primary Outcomes (1)

• OSDI Score

  Change in OSDI at Day 30 from Baseline (Statistical testing using one-sided one-sample t-test)

  30 Days from baseline

Secondary Outcomes (5)

• OSDI Score

  Day 14 and Day 90 from baseline

• Schirmer Test

  Day 30 and Day 90 from baseline

• Lipid Layer Thickness (Pre)

  Day 30 and Day 90 from baseline

• Lipid Layer Thickness (Pre vs Post)

  Day 14, Day 30, Day 90

• Corneal/Conjunctival Staining

  Day 30 and Day 90 from baseline

Study Arms (1)

Participants with iTEAR100 Neurostimulator

EXPERIMENTAL

The participants will use iTEAR100 Neurostimulator for the stimulation of the anterior ethmoidal nerve - which is located at the point between bony and fleshy tissue alongside the nose. Participants should apply stimulation to each side of the nose for 30 seconds, twice a day. It is recommended to apply once in the morning and once in the evening.

Device: iTEAR100 Neurostimulator

Interventions

iTEAR100 Neurostimulator DEVICE

To apply an iTEAR100 Neurostimulator for the stimulation to the anterior ethmoidal nerve - which is located at the point between bony and fleshy tissue alongside the nose. Participants should apply stimulation to each side of the nose for 30 seconds, twice a day. It is recommended to apply once in the morning and once in the evening.

Participants with iTEAR100 Neurostimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each patient must meet all the following criteria to be enrolled in this study:
• Provided informed consent, approved by the Institutional Review Board (IRB), to participate in the study.
• Reported use of artificial tears for DED within 30 days of Visit 1.
• Ocular Surface Disease Index (OSDI) ≥ 23 (with no more than 3 N/A in the answers).
• Anesthetized Schirmer Test Score ≤ 10 mm/5 min in at least one eye.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Used extranasal or intranasal neurostimulator within 30 days of Visit 1.
• Participation in any clinical trial with an investigational drug or device within 30 days of Visit 1.
• In the opinion of the investigator, any condition that could impair study participation/ocular evaluation or the potential risks of participation outweigh the potential benefits.

Sponsors & Collaborators

• The University of Hong Kong: lead
• ARCTIC VISION HONG KONG BIOTECH LIMITED: collaborator

Study Sites (1)

Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (14)

• Asbell PA, Maguire MG, Peskin E, Bunya VY, Kuklinski EJ; Dry Eye Assessment and Management (DREAM(c)) Study Research Group. Dry Eye Assessment and Management (DREAM(c)) Study: Study design and baseline characteristics. Contemp Clin Trials. 2018 Aug;71:70-79. doi: 10.1016/j.cct.2018.06.002. Epub 2018 Jun 6.

  PMID: 29883769 BACKGROUND

• Asbell P, Vingrys AJ, Tan J, Ogundele A, Downie LE, Jerkins G, Shettle L. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2275-2280. doi: 10.1167/iovs.17-23733.

  PMID: 29715369 BACKGROUND

• Friedman NJ, Butron K, Robledo N, Loudin J, Baba SN, Chayet A. A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease. Clin Ophthalmol. 2016 May 4;10:795-804. doi: 10.2147/OPTH.S101716. eCollection 2016.

  PMID: 27217719 BACKGROUND

• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

  PMID: 28736335 BACKGROUND

• Dieckmann GM, Cox SM, Lopez MJ, Ozmen MC, Yavuz Saricay L, Bayrakutar BN, Binotti WW, Henry E, Nau J, Hamrah P. A Single Administration of OC-01 (Varenicline Solution) Nasal Spray Induces Short-Term Alterations in Conjunctival Goblet Cells in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1551-1561. doi: 10.1007/s40123-022-00530-x. Epub 2022 Jun 2.

  PMID: 35653029 BACKGROUND

• Dieckmann, G., Kataguiri, P., Pondelis, N., Jamali, A., Alessandro Abbouda, salem, zeina, Franke, M., Senchyna, M., & Hamrah, P. (2017). In Vivo Confocal Microscopy Demonstrates Intranasal Neurostimulation-Induced Goblet Cell Alterations in Patients with Dry Eye Disease. Investigative Ophthalmology & Visual Science, 58(8), 2694-2694.

  BACKGROUND

• Eom Y, Lee JS, Kang SY, Kim HM, Song JS. Correlation between quantitative measurements of tear film lipid layer thickness and meibomian gland loss in patients with obstructive meibomian gland dysfunction and normal controls. Am J Ophthalmol. 2013 Jun;155(6):1104-1110.e2. doi: 10.1016/j.ajo.2013.01.008. Epub 2013 Mar 7.

  PMID: 23465270 BACKGROUND

• Gupta A, Heigle T, Pflugfelder SC. Nasolacrimal stimulation of aqueous tear production. Cornea. 1997 Nov;16(6):645-8.

  PMID: 9395874 BACKGROUND

• Ji MH, Moshfeghi DM, Periman L, Kading D, Matossian C, Walman G, Markham S, Mu A, Jayaram A, Gertner M, Karpecki P, Friedman NJ. Novel Extranasal Tear Stimulation: Pivotal Study Results. Transl Vis Sci Technol. 2020 Nov 17;9(12):23. doi: 10.1167/tvst.9.12.23. eCollection 2020 Nov.

  PMID: 33244443 BACKGROUND

• Kim J, Kim JY, Seo KY, Kim TI, Chin HS, Jung JW. Location and pattern of non-invasive keratographic tear film break-up according to dry eye disease subtypes. Acta Ophthalmol. 2019 Dec;97(8):e1089-e1097. doi: 10.1111/aos.14129. Epub 2019 May 6.

  PMID: 31062499 BACKGROUND

• Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.

  PMID: 28302532 BACKGROUND

• Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.

  PMID: 25931807 BACKGROUND

• Verjee MA, Brissette AR, Starr CE. Dry Eye Disease: Early Recognition with Guidance on Management and Treatment for Primary Care Family Physicians. Ophthalmol Ther. 2020 Dec;9(4):877-888. doi: 10.1007/s40123-020-00308-z. Epub 2020 Oct 22.

  PMID: 33090327 BACKGROUND

• Williamson JF, Huynh K, Weaver MA, Davis RM. Perceptions of dry eye disease management in current clinical practice. Eye Contact Lens. 2014 Mar;40(2):111-5. doi: 10.1097/ICL.0000000000000020.

  PMID: 24508770 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Allie LEE, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allie LEE, Dr.

CONTACT

(852) 3962 1405; aleeni@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

HK (1)