An interventional study of Povidone-Iodine 1 % Topical Solution and Eyelid cleansing wipes in Anterior Blepharitis, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once-daily eyelid hygiene with povidone-iodine 1%
Drug: Povidone-Iodine 1 % Topical Solution
Once-daily eyelid hygiene with available lid wipes
Drug: Eyelid cleansing wipes
Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily
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.
Time frame: 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.
Time frame: Day 30 (follow-up)
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time frame: Day 0 (recruitment)
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time frame: Day 30 (follow-up)
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Time frame: Day 0 (recruitment)
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Time frame: Day 30 (follow-up)
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Time frame: Day 0 (recruitment)
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Time frame: 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)
Time frame: Day 0 (recruitment)
National Eye Institute/Industry (NEI) grading scale
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
Time frame: Day 30 (follow-up)
Schirmer's test
with topical anesthetic (5 minutes, \>10mm is normal)
Time frame: Day 0 (recruitment)
Schirmer's test
with topical anesthetic (5 minutes, \>10mm is normal)
Time frame: Day 30 (follow-up)
Plan to share: No
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This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Povidone-Iodine