Anterior BlepharitisNCT05160623
Treatment of Blepharitis With Povidone-Iodine 1%
A study testing Povidone-Iodine 1 % Topical Solution and Eyelid cleansing wipes in people with Anterior Blepharitis, run by Shaare Zedek Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Blepharitis
- What is being tested?
- Povidone-Iodine 1 % Topical Solution and Eyelid cleansing wipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Aug 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Anterior or mixed (anterior + posterior) blepharitis.
- Similar clinical condition of both eyes.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ophthalmology clinic, Shaare Zedek Medical Center
Jerusalem, 9103102
Elishai Assayag, MD, elishai.assayag@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Blepharitis
- Being tested
- Povidone-Iodine 1 % Topical Solution, Eyelid cleansing wipes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine 1 % Topical SolutionDrug
Povidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily
Eyelid cleansing wipesDrug
EYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily
| Study group | Role | What they receive |
|---|---|---|
| Study eyes | Experimental | Once-daily eyelid hygiene with povidone-iodine 1% Receives: Drug: Povidone-Iodine 1 % Topical Solution |
| Control eyes | Active comparator | Once-daily eyelid hygiene with available lid wipes Receives: Drug: Eyelid cleansing wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 30 (follow-up)
Secondary outcomes (10)
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Measured: Day 0 (recruitment)
OSDI score
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Measured: Day 30 (follow-up)
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Measured: Day 0 (recruitment)
Subjective eye complaints
visual analog scale (VAS, 0-10 cm) of subjective eye complaints: itching, dryness, overall discomfort.
Measured: Day 30 (follow-up)
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Measured: Day 0 (recruitment)
TBUT
tear break-up time on slit-lamp examination (TBUT, 0-10 seconds)
Measured: 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)
Measured: Day 0 (recruitment)
National Eye Institute/Industry (NEI) grading scale
corneal staining- according to NEI grading system (0-15 score, 0-normal. 15-worse)
Measured: Day 30 (follow-up)
Schirmer's test
with topical anesthetic (5 minutes, >10mm is normal)
Measured: Day 0 (recruitment)
Schirmer's test
with topical anesthetic (5 minutes, >10mm is normal)
Measured: Day 30 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start16 Aug 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elishai Assayag, Shaare Zedek Medical Center
- Investigators
- Elishai Assayag, MD, Principal investigator, Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160623
- Sponsor's protocol ID
- 18004714
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Blepharitis With Povidone-Iodine 1% : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05160623
- Acronym / sponsor ID
- 18004714
- Conditions
- Anterior Blepharitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study eyes | Experimental | Drug: Povidone-Iodine 1 % Topical SolutionOnce-daily eyelid hygiene with povidone-iodine 1% |
| Control eyes | Active comparator | Drug: Eyelid cleansing wipesOnce-daily eyelid hygiene with available lid wipes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older.
- Anterior or mixed (anterior + posterior) blepharitis.
- Similar clinical condition of both eyes.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-Iodine 1 % Topical SolutionPovidone-Iodine 1 % topical solution on a makeup remover pad, used to clean the lids and lashes once daily | Drug | Study eyes |
| Eyelid cleansing wipesEYECARE FORTE eyelid wipes (Dr. Fischer, Israel), used to clean the lids and lashes once daily | Drug | Control eyes |
Primary outcome
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.
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.
10 secondary outcomes
OSDI score
Time frame: Day 0 (recruitment)
OSDI score
Time frame: Day 30 (follow-up)
Subjective eye complaints
Time frame: Day 0 (recruitment)
Subjective eye complaints
Time frame: Day 30 (follow-up)
TBUT
Time frame: Day 0 (recruitment)
TBUT
Time frame: Day 30 (follow-up)
National Eye Institute/Industry (NEI) grading scale
Time frame: Day 0 (recruitment)
National Eye Institute/Industry (NEI) grading scale
Time frame: Day 30 (follow-up)
Schirmer's test
Time frame: Day 0 (recruitment)
Schirmer's test
Time frame: Day 30 (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elishai Assayag, MD principal investigator
Department of Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine 1 % Topical Solution and Eyelid cleansing wipes in people with Anterior Blepharitis, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elishai Assayag, MD (+972556612130, elishai.assayag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blepharitis signs on slit-lamp examination (time frame: Day 0 (recruitment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.