To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.

Detailed Description
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Blepharitis is the most common condition in patients seeking an eye examination due to discomfort or eye irritation. Treatment of blepharitis is recommended even in mild cases as chronic inflammation may cause permanent damage to the Meibomian glands. Each eye of each patient represents an experimental unit. Each patient will apply Blephapad Combo to one eye and standard treatment to the other eye in accordance with the randomization procedure. The aim of this randomized, controlled study with a closed sequential design is to evaluate versus standard treatment the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.

Official Title
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Randomized, Controlled Study With a Closed Sequential Design to Compare the Efficacy, Safety and Patient Satisfaction of Blephapad Combo vs. Standard Treatment for Eyelid Cleansing in Patients Affected by Bilateral Posterior Blepharitis.

Conditions
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Bilateral Blepharitis (Disorder)

Intervention / Treatment
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* Combination Product: Blephapad Combo
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 40 years Male or female Diagnosis of bilateral posterior blepharitis Written informed consent of patient Exclusion Criteria: Treatment with topical ophthalmic drugs (artificial tears allowed) Ocular surgery in the previous 6 months Pregnant or breastfeeding women Alcohol abuse Psychiatric disorders Cognitive impairment that could affect evaluation of preferences Participation in other clinical studies in the last month Hypersensitivity to one or more components of the study products

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A randomized, controlled study with a closed sequential design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study treatment<br>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics. | Combination Product: Blephapad Combo<br>* Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia. The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.<br>|
| Other: Standard treatment<br>Wet, warm gauze twice daily for one month. | Other: Standard treatment<br>* Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) | The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome. The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features. | from baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes: Eye on Blephapad Combo: Improved-Eye on Standard: Improved Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as NOT improved,on the contrary if the change of the total score resulted negative the specific eye was referred as Improved. For each patient the results on the two eyes were combined. | From Visit 2 (baseline) to Visit 3 (week 4) | 
| Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment) | At the end of study patients was asked to state their preference on the treatments used. | at Visit 3 (week 4) |