Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-08-16
2022-12-31
Brief Summary
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Detailed Description
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Since no definitive cure is available, treatment recommendations for blepharitis focus on management. They may include eyelid hygiene using warm compresses and scrubbing, topical corticosteroids, topical and oral antibiotics, and dietary adjustments.
Povidone-iodine (PVI) is a widely used antimicrobial agent. Utilization of PVI is prevalent in disinfection of the eye and surrounding skin before intraocular procedures such as cataract surgeries and intravitreal injections. The antiseptic properties of PVI enable it to effectively reduce ocular surface and conjunctival colonization of various pathogens. Therefore, novel uses of ocular PVI seem promising, and some were already assessed in clinical studies.
The optimal concentration of PVI is also a matter of debate. High concentration solutions (5-10%) have greater potency, yet they increase corneal endothelial and epithelial toxicity. Although they may require repeated applications, low concentration solutions (0.1-1%) were proven to be safer and effective and are widely utilized in some countries. However, data regarding the option of treating blepharitis with PVI are lacking, as no comparative or controlled studies have been published to date.
In this study, the aim is to investigate the efficacy of lid scrubbing with PVI 1% in the treatment of anterior blepharitis
This is a prospective, controlled, randomized, observer-masked study. The allocated eye will be specified in a sealed envelope, given to the patient upon recruitment to the study. All investigators will be masked to the treated eye for the duration of the study. The fellow eye will serve as the control. Before treatment initiation, all outcomes will be assessed (specified below). Eligible participants will be assigned to use 1% PVI once daily on either the right or left eye for 30 days. During the first week of treatment, patients will be called to ensure the correct eye is being treated. Patients will be instructed to clean the eyelids and lashes of the study eye with 1% PVI using makeup remover pads (will be supplied to patients). Following treatment, patients will remove residual PVI with a wet makeup pad. The fellow eye (control eye) will receive regular treatment for blepharitis: eyelashes cleansing with commercially available eyelid wipes. Patients will be invited to a follow-up examination after 30 days. All outcomes will be re-assessed after 30 days of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study eyes
Once-daily eyelid hygiene with povidone-iodine 1%
Povidone-Iodine 1 % Topical Solution
Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
Control eyes
Once-daily eyelid hygiene with available lid wipes
Eyelid cleansing wipes
EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily
Interventions
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Povidone-Iodine 1 % Topical Solution
Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
Eyelid cleansing wipes
EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily
Eligibility Criteria
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Inclusion Criteria
* Anterior or mixed (anterior + posterior) blepharitis.
* Similar clinical condition of both eyes.
Exclusion Criteria
* Known allergy to iodine.
* Eye surgery in the last 6 months.
* Ocular trauma in the last 6 months.
* Use of contact lenses in the last 6 months.
* Pregnancy or lactation.
* Daily use of makeup on lashes.
* Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Elishai Assayag
Principal investigator
Principal Investigators
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Elishai Assayag, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
Locations
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Ophthalmology clinic, Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Elishai Assayag, MD
Role: primary
Other Identifiers
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18004714
Identifier Type: -
Identifier Source: org_study_id