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Treatment of Blepharitis With Povidone-Iodine 1%

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ClinicalTrials.gov Identifier: NCT05160623
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Elishai Assayag, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Anterior Blepharitis Drug: Povidone-Iodine 1 % Topical Solution Drug: Eyelid cleansing wipes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Blepharitis With Povidone-Iodine 1% : a Randomized Controlled Trial
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Blepharitis signs on slit-lamp examination [ Time Frame: Day 0 (recruitment) ]
    0-4 grading of each sign (normal, mild, moderate, severe, very severe): eyelid edema, eyelid erythema, scaling and crusting, meibomian glands clogging.

  2. Blepharitis signs on slit-lamp examination [ Time Frame: Day 30 (follow-up) ]
    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 :
  1. OSDI score [ Time Frame: Day 0 (recruitment) ]
    0-100 score based on the ocular surface disease index (OSDI) questionnaire

  2. OSDI score [ Time Frame: Day 30 (follow-up) ]
    0-100 score based on the ocular surface disease index (OSDI) questionnaire

  3. Subjective eye complaints [ Time Frame: Day 0 (recruitment) ]
    visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.

  4. Subjective eye complaints [ Time Frame: Day 30 (follow-up) ]
    visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.

  5. TBUT [ Time Frame: Day 0 (recruitment) ]
    tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)

  6. TBUT [ Time Frame: Day 30 (follow-up) ]
    tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)

  7. National Eye Institute/Industry (NEI) grading scale [ Time Frame: Day 0 (recruitment) ]
    corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)

  8. National Eye Institute/Industry (NEI) grading scale [ Time Frame: Day 30 (follow-up) ]
    corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)

  9. Schirmer's test [ Time Frame: Day 0 (recruitment) ]
    with topical anesthetic (5 minutes, >10mm is normal)

  10. Schirmer's test [ Time Frame: Day 30 (follow-up) ]
    with topical anesthetic (5 minutes, >10mm is normal)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160623


Contacts
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Contact: Elishai Assayag, MD +972556612130 elishai.assayag@gmail.com

Locations
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Israel
Ophthalmology clinic, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Elishai Assayag, MD       elishai.assayag@gmail.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Elishai Assayag, MD Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
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Responsible Party: Elishai Assayag, Principal investigator, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT05160623    
Other Study ID Numbers: 18004714
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases
Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents