Dry Eye DiseasePhase 4NCT06525961
iTear Single-center, Open-label, Single-arm Study
A Phase 4 study testing iTEAR100 Neurostimulator in people with Dry Eye Disease and Dry Eye Syndromes, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease, Dry Eye Syndromes, Dry Eye
- What is being tested?
- iTEAR100 Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2024to Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong
About this study
Official title: A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears
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.
Read more
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.
Read the detailed description
This is a Phase IV, single-centre, open-label, single-arm study to evaluate the effectiveness and safety of extra nasal neurostimulation in relieving symptoms of patients with Dry Eye Disease (DED) who are dissatisfied with artificial tear treatment. The intervention product is the extranasal neurostimulator, branded iTEAR.
The study duration is three months, with visits on Days 0, 30 and 90. Participants will follow a treatment regimen to apply neurostimulation to each side of the nose for 30 seconds twice daily for 30 days. From Day 31 to Day 90, participants will use the device as needed. Screening tests to measure baseline levels will be performed on Visit 1, and efficacy measures will be performed on Day 30 and Day 90. The participants will be instructed to perform a questionnaire on the ocular surface disease index (OSDI) on Day 14. Primary efficacy measures include changes in OSDI from baseline to Day 30. Secondary efficacy measures include the change in Schirmer Test Score, tear lipid layer thickness, corneal/conjunctival staining, and non-invasive tear film break-up time (NIBUT) from baseline to Day 30 and Day 90. Adverse Event (AE) Query is used as a safety measure to report adverse events in the duration of the study. The estimation of subjects in this trial is 30, with a power of 0.8 and assuming a 20% dropout rate.
To be included in the study, participants must be able to provide informed consent to participate in the study. They must have reported dissatisfaction (OSDI ≥ 23) with the recent use of artificial tears for DED (within 30 days of Visit 1), and Schirmer Test Score ≤ 10 mm/5 min in at least one eye.
The study eye will be defined as the eye with a Schirmer Test Score ≤ 10 mm/5 min. If both eyes qualify, the eye with a lower Schirmer Test Score during screening will be chosen as the study eye. If there is no difference, the right eye will be selected as the study eye.
The participants are excluded from the study if they have used extranasal or intranasal neurostimulator within 30 days of Visit 1, or participated in any clinical trial with an investigational substance 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 will also lead to exclusion from the study.
The participants will be withdrawn from the study if they voluntarily withdraw their consent to study participation, develop any adverse event that prevents the study participation, persistently do not comply with the study protocol, are lost to follow-up, or when the investigator believes the risk of further subject participation outweighs the benefit.
- Being tested
- iTEAR100 Neurostimulator
- Keywords
- Dry Eye, DED, Dry Eye Syndromes, Meibomian Gland Dysfunction (MGD)
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTEAR100 NeurostimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iTEAR100 Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI Score
Change in OSDI at Day 30 from Baseline (Statistical testing using one-sided one-sample t-test)
Measured: 30 Days from baseline
Secondary outcomes (5)
OSDI Score
- Change in OSDI from baseline to Day 14 and Day 90
Measured: Day 14 and Day 90 from baseline
Schirmer Test
- Change in Schirmer Test Score from baseline to Day 30 and Day 90
Measured: Day 30 and Day 90 from baseline
Lipid Layer Thickness (Pre)
- Change in tear lipid layer thickness (pre-stimulation) from baseline to Day 30 and Day 90
Measured: Day 30 and Day 90 from baseline
Lipid Layer Thickness (Pre vs Post)
- Change between pre-stimulation and post-stimulation of tear lipid layer thickness in each visit
Measured: Day 14, Day 30, Day 90
Corneal/Conjunctival Staining
- Change in Corneal/Conjunctival Staining from baseline to Day 30 and Day 90
Measured: Day 30 and Day 90 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- ARCTIC VISION HONG KONG BIOTECH LIMITED
- Responsible party
- Principal investigator, Allie Lee, The University of Hong Kong
- Investigators
- Allie LEE, Dr., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525961
- Sponsor's protocol ID
- itear2024
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 29883769Asbell 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.
PubMed 29715369Friedman 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.
PubMed 27217719Craig 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.
PubMed 28736335Dieckmann 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.
PubMed 35653029Dieckmann, 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.
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.
PubMed 23465270Gupta A, Heigle T, Pflugfelder SC. Nasolacrimal stimulation of aqueous tear production. Cornea. 1997 Nov;16(6):645-8.
PubMed 9395874Ji 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.
PubMed 33244443Kim 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.
PubMed 31062499Gumus 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.
PubMed 28302532Simmons 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.
PubMed 25931807Verjee 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.
PubMed 33090327Williamson 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.
PubMed 24508770
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears
- ClinicalTrials.gov ID
- NCT06525961
- Acronym / sponsor ID
- itear2024
- Keywords
- Dry Eye, DED, Dry Eye Syndromes, Meibomian Gland Dysfunction (MGD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- ARCTIC VISION HONG KONG BIOTECH LIMITED
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase IV, single-centre, open-label, single-arm study to evaluate the effectiveness and safety of extra nasal neurostimulation in relieving symptoms of patients with Dry Eye Disease (DED) who are dissatisfied with artificial tear treatment. The intervention product is the extranasal neurostimulator, branded iTEAR.
The study duration is three months, with visits on Days 0, 30 and 90. Participants will follow a treatment regimen to apply neurostimulation to each side of the nose for 30 seconds twice daily for 30 days. From Day 31 to Day 90, participants will use the device as needed. Screening tests to measure baseline levels will be performed on Visit 1, and efficacy measures will be performed on Day 30 and Day 90. The participants will be instructed to perform a questionnaire on the ocular surface disease index (OSDI) on Day 14. Primary efficacy measures include changes in OSDI from baseline to Day 30. Secondary efficacy measures include the change in Schirmer Test Score, tear lipid layer thickness, corneal/conjunctival staining, and non-invasive tear film break-up time (NIBUT) from baseline to Day 30 and Day 90. Adverse Event (AE) Query is used as a safety measure to report adverse events in the duration of the study. The estimation of subjects in this trial is 30, with a power of 0.8 and assuming a 20% dropout rate.
To be included in the study, participants must be able to provide informed consent to participate in the study. They must have reported dissatisfaction (OSDI ≥ 23) with the recent use of artificial tears for DED (within 30 days of Visit 1), and Schirmer Test Score ≤ 10 mm/5 min in at least one eye.
The study eye will be defined as the eye with a Schirmer Test Score ≤ 10 mm/5 min. If both eyes qualify, the eye with a lower Schirmer Test Score during screening will be chosen as the study eye. If there is no difference, the right eye will be selected as the study eye.
The participants are excluded from the study if they have used extranasal or intranasal neurostimulator within 30 days of Visit 1, or participated in any clinical trial with an investigational substance 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 will also lead to exclusion from the study.
The participants will be withdrawn from the study if they voluntarily withdraw their consent to study participation, develop any adverse event that prevents the study participation, persistently do not comply with the study protocol, are lost to follow-up, or when the investigator believes the risk of further subject participation outweighs the benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with iTEAR100 Neurostimulator | Experimental | Device: iTEAR100 NeurostimulatorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTEAR100 NeurostimulatorTo 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. | Device | Participants with iTEAR100 Neurostimulator |
Primary outcome
OSDI Score
Time frame: 30 Days from baseline
Change in OSDI at Day 30 from Baseline (Statistical testing using one-sided one-sample t-test)
5 secondary outcomes
OSDI Score
Time frame: Day 14 and Day 90 from baseline
Schirmer Test
Time frame: Day 30 and Day 90 from baseline
Lipid Layer Thickness (Pre)
Time frame: Day 30 and Day 90 from baseline
Lipid Layer Thickness (Pre vs Post)
Time frame: Day 14, Day 30, Day 90
Corneal/Conjunctival Staining
Time frame: Day 30 and Day 90 from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 29883769Asbell 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.
- Background: PubMed 29715369Asbell 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.
- Background: PubMed 27217719Friedman 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.
- Background: PubMed 28736335Craig 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.
- Background: PubMed 35653029Dieckmann 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.
- BackgroundDieckmann, 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: PubMed 23465270Eom 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.
- Background: PubMed 9395874Gupta A, Heigle T, Pflugfelder SC. Nasolacrimal stimulation of aqueous tear production. Cornea. 1997 Nov;16(6):645-8.
- Background: PubMed 33244443Ji 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.
- Background: PubMed 31062499Kim 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.
- Background: PubMed 28302532Gumus 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.
- Background: PubMed 25931807Simmons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allie LEE, Dr. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iTEAR100 Neurostimulator in people with Dry Eye Disease and Dry Eye Syndromes, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allie LEE, Dr. ((852) 3962 1405, aleeni@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI Score (time frame: 30 Days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525961, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.