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Status unknownNCT05160623Updated Dec 16, 2021

Treatment of Blepharitis With Povidone-Iodine 1%

An interventional study of Povidone-Iodine 1 % Topical Solution and Eyelid cleansing wipes in Anterior Blepharitis, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

One hundred blepharitis patients will be recruited. Each patient will treat one eye once daily with 1% PVI for 30 days by scrubbing the eyelid margin with the solution. The fellow eye will serve as the control and be given the standard treatment (commercial eye wipes). Before treatment initiation, various ocular surface variables will be assessed, such as dry eye grading, subjective discomfort scales, ocular surface questionnaire, and other clinical signs. After 30 days, an identical evaluation will be performed.

Read the detailed description

Blepharitis is a chronic and very common inflammation of the eyelid margin affecting patients of all ages. This condition can be categorized anatomically (anterior- skin and eyelashes, posterior- meibomian glands), and pathophysiologically (staphylococcal, seborrheic, parasitic [Demodex mites], and meibomian gland dysfunction [MGD]). Combined forms of the disease are not uncommon. Signs and symptoms include itching, redness, flaking, and crusting of the lids, along with ocular surface disturbances such as irritation, dryness, tearing, and corneal damage.

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.

02

Conditions studied

  • Anterior Blepharitis

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03

In context

Blepharitis

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 →

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Age 18 or older.
  • Anterior or mixed (anterior + posterior) blepharitis.
  • Similar clinical condition of both eyes.

Exclusion criteria

Exclusion Criteria:

  • Any ocular surface disease other than blepharitis.
  • 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, , ).
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Study eyes

    Once-daily eyelid hygiene with povidone-iodine 1%

    Drug: Povidone-Iodine 1 % Topical Solution

  • Active comparator
    Control eyes

    Once-daily eyelid hygiene with available lid wipes

    Drug: Eyelid cleansing wipes

Interventions

  • Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily

  • DrugEyelid cleansing wipes

    EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily

06

What researchers measure

Primary outcomes

  1. Blepharitis signs on slit-lamp examination

    0-4 grading of each sign (normal, mild, moderate, severe, very severe): eyelid edema, eyelid erythema, scaling and crusting, meibomian glands clogging.

    Time frame: Day 0 (recruitment)

  2. Blepharitis signs on slit-lamp examination

    0-4 grading of each sign (normal, mild, moderate, severe, very severe): eyelid edema, eyelid erythema, scaling and crusting, meibomian glands clogging.

    Time frame: Day 30 (follow-up)

Secondary outcomes

  1. OSDI score

    0-100 score based on the ocular surface disease index (OSDI) questionnaire

    Time frame: Day 0 (recruitment)

  2. OSDI score

    0-100 score based on the ocular surface disease index (OSDI) questionnaire

    Time frame: Day 30 (follow-up)

  3. Subjective eye complaints

    visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.

    Time frame: Day 0 (recruitment)

  4. Subjective eye complaints

    visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.

    Time frame: Day 30 (follow-up)

  5. TBUT

    tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)

    Time frame: Day 0 (recruitment)

  6. TBUT

    tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)

    Time frame: Day 30 (follow-up)

  7. National Eye Institute/Industry (NEI) grading scale

    corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)

    Time frame: Day 0 (recruitment)

  8. National Eye Institute/Industry (NEI) grading scale

    corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)

    Time frame: Day 30 (follow-up)

  9. Schirmer's test

    with topical anesthetic (5 minutes, \>10mm is normal)

    Time frame: Day 0 (recruitment)

  10. Schirmer's test

    with topical anesthetic (5 minutes, \>10mm is normal)

    Time frame: Day 30 (follow-up)

07

Study locations

1 of 1 sites recruiting
  • Ophthalmology clinic, Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160623
Responsible party
Elishai Assayag (Principal investigator, Shaare Zedek Medical Center) — Principal investigator
First posted
Dec 16, 2021
Start date
Aug 16, 2021
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 16, 2021

Study contacts

Elishai Assayag, MD
Contact
elishai.assayag@gmail.com
+972556612130
Elishai Assayag, MD
principal investigator · Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Povidone-Iodine

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