Treatment of Blepharitis With Povidone-Iodine 1%

NCT05160623 | Unknown

• 1 other identifier: 18004714
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Blepharitis

Outcome Measures

Primary Outcomes (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.

  Day 0 (recruitment)

• 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.

  Day 30 (follow-up)

Secondary Outcomes (10)

• OSDI score

  Day 0 (recruitment)

• OSDI score

  Day 30 (follow-up)

• Subjective eye complaints

  Day 0 (recruitment)

• Subjective eye complaints

  Day 30 (follow-up)

• TBUT

  Day 0 (recruitment)

Study Arms (2)

Study eyes

EXPERIMENTAL

Once-daily eyelid hygiene with povidone-iodine 1%

Drug: Povidone-Iodine 1 % Topical Solution

Control eyes

ACTIVE COMPARATOR

Once-daily eyelid hygiene with available lid wipes

Drug: Eyelid cleansing wipes

Interventions

Povidone-Iodine 1 % Topical Solution DRUG

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

Study eyes

Eyelid cleansing wipes DRUG

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

Control eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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, immunosuppressants, steroids).

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Ophthalmology clinic, Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

MeSH Terms

Interventions

Povidone-Iodine; Solutions

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Preparations

Study Officials

• Elishai Assayag, MD

  Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elishai Assayag, MD

CONTACT

+972556612130; elishai.assayag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A prospective, controlled, randomized, observer-masked study. One eye will be allocated for the studied treatment, and the fellow (control) eye will receive the standard treatment.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 16, 2021
• Study Start: August 16, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)