Dry EyeNCT04667819
Wireless Micropump in Dry Eye Patients
A study testing Sodium Hyaluronate in people with Dry Eye, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sodium Hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Mar 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elimination of serious mental and psychological diseases;
- be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- be willing to comply with the clinical trial visit schedule as directed by the investigator;
- at baseline, be within the age range of 18 to 80 years old inclusive;
- BCVA≥1.0 of both eyes for each patient;
- dry eye test is BUT<5s and or Schimer test<5mm/5min；
- without other ophthalmic diseases;
Who cannot join
- At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed;
- serious mental and psychological diseases;
- history of refractive surgery;
- nystagmus or failure to cooperate;
- history of intraocular surgery;
- patients with systemic diseases (such as diabetes, hypertension, heart disease, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin
Yan Wang, director, +86-02227305083, wangyan7143@vip.sina.com
About this study
Official title: Clinical Efficacy of Wireless Micropump in Dry Eye Patients
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.
Read the detailed description
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.
- Conditions
- Dry Eye
- Being tested
- Sodium Hyaluronate
- Keywords
- micropump, dry eye, sodium hyaluronate
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.
| Study group | Role | What they receive |
|---|---|---|
| sodium hyaluronate | Experimental | Sodium hyaluronate has become a novel and effective eye drop for the treatment of the dry eye. However, we design a special method of usage of sodium hyaluronate in dry eye patients. Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear film break-up time
change before and after sodium hyaluronate with OCCULUS
Measured: change from baseline with OCCULUS at 6 months
tear film thickness
change before and after sodium hyaluronate with OCCULUS
Measured: change from baseline with OCCULUS at 6 months
corneal epithelium defect percentage
change before and after sodium hyaluronate with OCCULUS
Measured: change from baseline with OCCULUS at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study director, Tianjin Eye HospitalXuexin Duan, professor, Principal investigator, Tianjin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667819
- Sponsor's protocol ID
- 202076
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Resto PJ, Berthier E, Beebe DJ, Williams JC. An inertia enhanced passive pumping mechanism for fluid flow in microfluidic devices. Lab Chip. 2012 Jun 21;12(12):2221-8. doi: 10.1039/c2lc20858j. Epub 2012 Mar 23.
PubMed 22441561Kamal T, Watkins R, Cen Z, Rubinstein J, Kong G, Lee WM. Design and fabrication of a passive droplet dispenser for portable high resolution imaging system. Sci Rep. 2017 Jan 27;7:41482. doi: 10.1038/srep41482.
PubMed 28128365Kwon JW, Kim JS, Choi SB, Lee JH, Wee WR. Experimental study of an automated system for the delivery of eyedrops using a microinfusion pump. Am J Ophthalmol. 2005 Mar;139(3):547-9. doi: 10.1016/j.ajo.2004.08.051.
PubMed 15767073Huang PH, Nama N, Mao Z, Li P, Rufo J, Chen Y, Xie Y, Wei CH, Wang L, Huang TJ. A reliable and programmable acoustofluidic pump powered by oscillating sharp-edge structures. Lab Chip. 2014 Nov 21;14(22):4319-23. doi: 10.1039/c4lc00806e.
PubMed 25188786Wu Z, Cai H, Ao Z, Nunez A, Liu H, Bondesson M, Guo S, Guo F. A Digital Acoustofluidic Pump Powered by Localized Fluid-Substrate Interactions. Anal Chem. 2019 Jun 4;91(11):7097-7103. doi: 10.1021/acs.analchem.9b00069. Epub 2019 May 14.
PubMed 31083981
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Wireless Micropump in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT04667819
- Acronym / sponsor ID
- 202076
- Conditions
- Dry Eye
- Keywords
- micropump, dry eye, sodium hyaluronate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Collaborators
- Tianjin University
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 16 Dec 2020 (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.
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.
Detailed description
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sodium hyaluronate | Experimental | Drug: Sodium HyaluronateSodium hyaluronate has become a novel and effective eye drop for the treatment of the dry eye. However, we design a special method of usage of sodium hyaluronate in dry eye patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- elimination of serious mental and psychological diseases;
- be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- be willing to comply with the clinical trial visit schedule as directed by the investigator;
- at baseline, be within the age range of 18 to 80 years old inclusive;
- BCVA≥1.0 of both eyes for each patient;
Key exclusion criteria (6 listed)
- At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed;
- serious mental and psychological diseases;
- history of refractive surgery;
- nystagmus or failure to cooperate;
- history of intraocular surgery;
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 |
|---|---|---|
| Sodium HyaluronateWe usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients. | Drug | sodium hyaluronate |
Primary outcome
tear film break-up time
Time frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
tear film thickness
Time frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
corneal epithelium defect percentage
Time frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Results publication: PubMed 22441561Resto PJ, Berthier E, Beebe DJ, Williams JC. An inertia enhanced passive pumping mechanism for fluid flow in microfluidic devices. Lab Chip. 2012 Jun 21;12(12):2221-8. doi: 10.1039/c2lc20858j. Epub 2012 Mar 23.
- Results publication: PubMed 28128365Kamal T, Watkins R, Cen Z, Rubinstein J, Kong G, Lee WM. Design and fabrication of a passive droplet dispenser for portable high resolution imaging system. Sci Rep. 2017 Jan 27;7:41482. doi: 10.1038/srep41482.
- Results publication: PubMed 15767073Kwon JW, Kim JS, Choi SB, Lee JH, Wee WR. Experimental study of an automated system for the delivery of eyedrops using a microinfusion pump. Am J Ophthalmol. 2005 Mar;139(3):547-9. doi: 10.1016/j.ajo.2004.08.051.
- Results publication: PubMed 25188786Huang PH, Nama N, Mao Z, Li P, Rufo J, Chen Y, Xie Y, Wei CH, Wang L, Huang TJ. A reliable and programmable acoustofluidic pump powered by oscillating sharp-edge structures. Lab Chip. 2014 Nov 21;14(22):4319-23. doi: 10.1039/c4lc00806e.
- Results publication: PubMed 31083981Wu Z, Cai H, Ao Z, Nunez A, Liu H, Bondesson M, Guo S, Guo F. A Digital Acoustofluidic Pump Powered by Localized Fluid-Substrate Interactions. Anal Chem. 2019 Jun 4;91(11):7097-7103. doi: 10.1021/acs.analchem.9b00069. Epub 2019 May 14.
- Individual participant dataSharing planned: No
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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.
Yan Wang, director study director
Tianjin Eye Hospital
Xuexin Duan, professor principal investigator
Tianjin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hyaluronate in people with Dry Eye, run by Tianjin Eye Hospital at 1 site in China.
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 7 inclusion and 6 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 16 Dec 2020. 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 China. 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.
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 Yan Wang, director (+862227313336, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tear film break-up time (time frame: change from baseline with OCCULUS at 6 months). The study lists 3 primary outcomes in all. 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 NCT04667819, which also lists 5 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 16 Dec 2020.