An interventional study of Avenova Lid Cleanser in Blepharitis, sponsored by Minnesota Eye Consultants, P.A.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Minnesota Eye Consultants, P.A. · Not applicable, Interventional, and Treatment
The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.
This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Minnesota Eye Consultants, P.A. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One eye will be treated with Avenova; the other eye will not be treated. The investigator is masked as to which eye is receiving Avenova product.
Device: Avenova Lid Cleanser
One eye will be treated with Avenova; the other eye will not will be treated. The investigator is masked as to which eye is receiving Avenova product.
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
Change in Severity of Markers of Inflammation
Clinical parameters include prevalence of demodex mites.
Time frame: 30 days
Change in Severity of Markers of Inflammation
Clinical exam parameters include prevalence of tear film break up time.
Time frame: 30 days
Change in Severity of Markers of Inflammation
Clinical exam parameters include corneal and conjunctival staining.
Time frame: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..
Time frame: 30 days
Change in Severity of Markers of Inflammation using tear osmolarity.
Clinical parameters include tear osmolarity.
Time frame: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include tear ferning patterns.
Time frame: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include meibomian gland evaluation
Time frame: 30 days
Change in Ocular Discomfort
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Time frame: 30 days
Change in Ocular Discomfort
Change in ocular discomfort based on scores from Ocular Surface Disease Index questionnaire. Scored on a scale of 0-100, with higher scores indicating greater disability.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Minnesota Eye Consultants, P.A.