An interventional study of 0.01% hypochlorous acid and Placebo in Blepharitis, sponsored by Eye & ENT Hospital of Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.01%hypochlorous acid group
Drug: 0.01% hypochlorous acid
eyelid wipes
Drug: Placebo
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
Also known as: 0.01%HOCI
once daily eyelid wipes for 2 weeks
OSDI
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time frame: 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.
Time frame: Change from baseline meibum quality score at 2 weeks
Corneal fluorescein staining
scored by Oxford staining score
Time frame: Change from baseline corneal fluorescein staining at 2 weeks
FBUT
fluorescent tear break up time fluorescein tear film break-up time
Time frame: Change from baseline FTBUT at 2 weeks
Started Jul 2022 (actual). Primary completion is estimated for Dec 2022, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hypochlorous Acid
Eye & ENT Hospital of Fudan University →