BlepharitisNCT05608980
0.01% Hypochlorous Acid in the Treatment of Blepharitis
A study testing 0.01% hypochlorous acid in people with Blepharitis, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- 0.01% hypochlorous acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Anterior or mixed (anterior + posterior) blepharitis.
- Similar clinical condition of both eyes.
- A negative urine pregnancy test result for women of childbearing potential
- Normal lid position and closure
- Ability to understand and provide informed consent to participate in this study
- Willingness to follow study instructions and likely to complete all required visits.
Who cannot join
- Any ocular surface disease other than blepharitis.
- Known allergy to hypochlorous acid or boric acid.
- Eye surgery in the last 6 months.
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Ocular trauma in the last 6 months.
- Use of contact lenses in the last 6 months.
Show all 13Show fewer
- Pregnancy or lactation.
- Daily use of makeup on lashes.
- Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
- Pregnant or lactating women
- Signs of current infection, including fever and current treatment with antibiotics
- Liver, renal, or hematologic disease
- The use of any other investigational drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
Jiaxu Hong, phD, 13917440201, jiaxu_hong@163.com
Hong Zhang, MsC
About this study
Official title: Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
- Conditions
- Blepharitis
- Being tested
- 0.01% hypochlorous acid, Placebo
- Keywords
- Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction
- Medical subject headings
- Blepharitis, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% hypochlorous acidDrug
Also called 0.01%HOCI
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
PlaceboDrug
once daily eyelid wipes for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | 0.01%hypochlorous acid group Receives: Drug: 0.01% hypochlorous acid |
| Placebo | Placebo comparator | eyelid wipes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Measured: Change from baseline OSDI at 2 weeks
meibum quality
Meibum quality were measured by using firm digital pressure applied over 5 lower lid glands. Meibum quality was graded as: grade 0, clear; grade 1, cloudy; grade 2, cloudy with granular debris; and grade 3, thick like toothpaste.
Measured: Change from baseline meibum quality score at 2 weeks
Corneal fluorescein staining
scored by Oxford staining score
Measured: Change from baseline corneal fluorescein staining at 2 weeks
FBUT
fluorescent tear break up time fluorescein tear film break-up time
Measured: Change from baseline FTBUT at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jul 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, controlled, randomized study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- ShuGuang Hospital
- Responsible party
- Sponsor
- Investigators
- Jiaxu Hong, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608980
- Sponsor's protocol ID
- 0.01% Hypochlorous Acid
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05608980
- Acronym / sponsor ID
- 0.01% Hypochlorous Acid
- Conditions
- Blepharitis
- Keywords
- Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- ShuGuang Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 8 Nov 2022 (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 is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, controlled, randomized study.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: 0.01% hypochlorous acid0.01%hypochlorous acid group |
| Placebo | Placebo comparator | Drug: Placeboeyelid wipes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older.
- Anterior or mixed (anterior + posterior) blepharitis.
- Similar clinical condition of both eyes.
- A negative urine pregnancy test result for women of childbearing potential
- Normal lid position and closure
Key exclusion criteria (13 listed)
- Any ocular surface disease other than blepharitis.
- Known allergy to hypochlorous acid or boric acid.
- Eye surgery in the last 6 months.
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Ocular trauma in the last 6 months.
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 |
|---|---|---|
| 0.01% hypochlorous acidAlso: 0.01%HOCIonce daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks | Drug | Treatment arm |
| Placeboonce daily eyelid wipes for 2 weeks | Drug | Placebo |
Primary outcome
OSDI
Time frame: Change from baseline OSDI at 2 weeks
0-100 score based on the ocular surface disease index (OSDI) questionnaire
meibum quality
Time frame: Change from baseline meibum quality score at 2 weeks
Meibum quality were measured by using firm digital pressure applied over 5 lower lid glands. Meibum quality was graded as: grade 0, clear; grade 1, cloudy; grade 2, cloudy with granular debris; and grade 3, thick like toothpaste.
Corneal fluorescein staining
Time frame: Change from baseline corneal fluorescein staining at 2 weeks
scored by Oxford staining score
FBUT
Time frame: Change from baseline FTBUT at 2 weeks
fluorescent tear break up time fluorescein tear film break-up time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
Jiaxu Hong principal investigator
Eye & ENT Hospital of Fudan 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 0.01% hypochlorous acid in people with Blepharitis, run by Eye & ENT Hospital of Fudan 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 7 inclusion and 13 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 8 Nov 2022. 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. Some participants in this study may receive a placebo. 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 Jiaxu Hong (13917440201, jiaxu_hong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: Change from baseline OSDI at 2 weeks). The study lists 4 primary outcomes in all. 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 8 Nov 2022.