Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05160623 |
| Other study ID # |
18004714 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2021 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Shaare Zedek Medical Center |
| Contact |
Elishai Assayag, MD |
| Phone |
+972556612130 |
| Email |
elishai.assayag[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
