Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland DysfunctionNCT04569422
Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients
An observational study of Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
In this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. Therefore, we needed to collect patients' pain grades during meibomian gland massage Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction
- What is being tested?
- Benoxyl
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 21 May 2021
- Phase
- Observational
- 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
Study population: Meibomian gland dysfunction people with no chronic disease
Who may be able to join
- Healthy people with no chronic disease
Who cannot join
- People with chronic disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Aier School of Ophthalmology, Central South University
Changsha, Hunan
Shibo Tang, Prof, 00-86-0755-23809666, tangshibo@vip.163.com
About this study
In this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. Therefore, we needed to collect patients' pain grades during meibomian gland massage
Read the detailed description
Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.
Methods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scaleMethods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scale Group: Divided into ephedrine drop group and artificial tear drop group Research tool: Pain rating scale
- Conditions
- Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction
- Being tested
- Benoxyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenoxylDrug
reduce pain
| Study group | Role | What they receive |
|---|---|---|
| ephedrine drop | Not described Receives: Drug: Benoxyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undifferrentiated
There was no difference in the effect of obuvacaine hydrochloride on the comfort of meibomian gland massage patients
Measured: 2020.01-2020.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Jun 2020
- Primary completion21 Mar 2021 (estimated)
- Study completion21 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JJiang Junyi, Aier School of Ophthalmology, Central South University
- Investigators
- Yuanyuan Yin, bachelor, Principal investigator, Shanghai Aier Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569422
- Sponsor's protocol ID
- 2020-002-01
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients
- ClinicalTrials.gov ID
- NCT04569422
- Acronym / sponsor ID
- 2020-002-01
- Conditions
- Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 21 Mar 2021 (estimated)
- Study completion
- 21 May 2021 (estimated)
- First posted
- 29 Sep 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.
In this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. Therefore, we needed to collect patients' pain grades during meibomian gland massage
Detailed description
Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.
Methods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scaleMethods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scale Group: Divided into ephedrine drop group and artificial tear drop group Research tool: Pain rating scale
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ephedrine drop | – | Drug: Benoxyl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Meibomian gland dysfunction people with no chronic disease
Key inclusion criteria (1 listed)
- Healthy people with no chronic disease
Key exclusion criteria (1 listed)
- People with chronic disease
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 |
|---|---|---|
| Benoxylreduce pain | Drug | ephedrine drop |
Primary outcome
Undifferrentiated
Time frame: 2020.01-2020.09
There was no difference in the effect of obuvacaine hydrochloride on the comfort of meibomian gland massage patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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.
Yuanyuan Yin, bachelor principal investigator
Shanghai Aier Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction, run by Aier School of Ophthalmology, Central South University 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 1 inclusion and 1 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 Sep 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 Yuanyuan Yin, bachelor (18621755180, 815969138@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undifferrentiated (time frame: 2020.01-2020.09). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.