Treatment of Blepharitis With Povidone-Iodine 1%

Treatment of Blepharitis With Povidone-Iodine 1% : a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Blepharitis
• Intervention / Treatment: Drug: Povidone-Iodine 1 % Topical Solution; Drug: Eyelid cleansing wipes

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elishai Assayag, MD; Phone Number: +972556612130; Email: elishai.assayag@gmail.com

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Ophthalmology clinic, Shaare Zedek Medical Center
    • Contact: Elishai Assayag, MD; Email: elishai.assayag@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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, immunosuppressants, steroids).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study eyes; Once-daily eyelid hygiene with povidone-iodine 1%	Drug: Povidone-Iodine 1 % Topical Solution; Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
Active Comparator: Control eyes; Once-daily eyelid hygiene with available lid wipes	Drug: Eyelid cleansing wipes; EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI score	0-100 score based on the ocular surface disease index (OSDI) questionnaire	Day 0 (recruitment)
OSDI score	0-100 score based on the ocular surface disease index (OSDI) questionnaire	Day 30 (follow-up)
Subjective eye complaints	visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.	Day 0 (recruitment)
Subjective eye complaints	visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.	Day 30 (follow-up)
TBUT	tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)	Day 0 (recruitment)
TBUT	tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)	Day 30 (follow-up)
National Eye Institute/Industry (NEI) grading scale	corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)	Day 0 (recruitment)
National Eye Institute/Industry (NEI) grading scale	corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)	Day 30 (follow-up)
Schirmer's test	with topical anesthetic (5 minutes, >10mm is normal)	Day 0 (recruitment)
Schirmer's test	with topical anesthetic (5 minutes, >10mm is normal)	Day 30 (follow-up)

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Elishai Assayag, MD, Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 18004714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No