Treatment of Blepharitis With Povidone-Iodine 1%
Primary Purpose
Anterior Blepharitis
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Povidone-Iodine 1 % Topical Solution
Eyelid cleansing wipes
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Blepharitis
Eligibility Criteria
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).
Sites / Locations
- Ophthalmology clinic, Shaare Zedek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study eyes
Control eyes
Arm Description
Once-daily eyelid hygiene with povidone-iodine 1%
Once-daily eyelid hygiene with available lid wipes
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
National Eye Institute/Industry (NEI) grading scale
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
National Eye Institute/Industry (NEI) grading scale
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
Schirmer's test
with topical anesthetic (5 minutes, >10mm is normal)
Schirmer's test
with topical anesthetic (5 minutes, >10mm is normal)
Full Information
NCT ID
NCT05160623
First Posted
November 30, 2021
Last Updated
December 15, 2021
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05160623
Brief Title
Treatment of Blepharitis With Povidone-Iodine 1%
Official Title
Treatment of Blepharitis With Povidone-Iodine 1% : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study eyes
Arm Type
Experimental
Arm Description
Once-daily eyelid hygiene with povidone-iodine 1%
Arm Title
Control eyes
Arm Type
Active Comparator
Arm Description
Once-daily eyelid hygiene with available lid wipes
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine 1 % Topical Solution
Intervention Description
Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
Intervention Type
Drug
Intervention Name(s)
Eyelid cleansing wipes
Intervention Description
EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily
Primary Outcome Measure Information:
Title
Blepharitis signs on slit-lamp examination
Description
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)
Title
Blepharitis signs on slit-lamp examination
Description
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 Outcome Measure Information:
Title
OSDI score
Description
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time Frame
Day 0 (recruitment)
Title
OSDI score
Description
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time Frame
Day 30 (follow-up)
Title
Subjective eye complaints
Description
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Time Frame
Day 0 (recruitment)
Title
Subjective eye complaints
Description
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Time Frame
Day 30 (follow-up)
Title
TBUT
Description
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Time Frame
Day 0 (recruitment)
Title
TBUT
Description
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Time Frame
Day 30 (follow-up)
Title
National Eye Institute/Industry (NEI) grading scale
Description
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
Time Frame
Day 0 (recruitment)
Title
National Eye Institute/Industry (NEI) grading scale
Description
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
Time Frame
Day 30 (follow-up)
Title
Schirmer's test
Description
with topical anesthetic (5 minutes, >10mm is normal)
Time Frame
Day 0 (recruitment)
Title
Schirmer's test
Description
with topical anesthetic (5 minutes, >10mm is normal)
Time Frame
Day 30 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elishai Assayag, MD
Phone
+972556612130
Email
elishai.assayag@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elishai Assayag, MD
Organizational Affiliation
Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology clinic, Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elishai Assayag, MD
Email
elishai.assayag@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Blepharitis With Povidone-Iodine 1%
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