Posters

Efficacy and safety comparison of blephapad combo vs standard care for the treatment of bilateral posterior blepharitis

Poster Details

First Author: V.Scorcia ITALY

Co Author(s):    V. De Luca   A. Carnevali                 

Abstract Details

Purpose:

Posterior blepharitis is characterized by a dysfunction of the Meibomian glands representing a common condition in patients complaining of eye discomfort or irritation; treatment is recommended even in asymptomatic or mild cases as chronic inflammation may cause permanent damage to the Meibomian glands. Daily cleansing of eyelids and cilia is essential as it removes debris, softens thickened secretions, removes ciliary dandruff and cleans the eyelid margin. The purpose of this study is to evaluate the efficacy, safety and patient satisfaction of Blephapad Combo in the treatment of posterior blepharitis

Setting:

This randomized, controlled study with a closed sequential design was conducted on patients older than 40-year, affected by bilateral posterior blepharitis, who were referred to the Ophthalmology Department of “Magna Graecia” University of Catanzaro, Italy

Methods:

Each patient applied study treatment on one eye and standard treatment (warm packs and eyelid hygiene) on the other, twice daily for one month, as per randomization. Changes from baseline at end of treatment for both eyes were evaluated using grading scales for Meibomian Gland Dysfunction (MGD). A closed sequential design with diagram detected medium-sized differences between treatments at the 10% α level. The better change between new and standard treatment was plotted sequentially; no marks were placed when a choice could not be made between the two treatments. The study ended when the plot line reached the Blephapad boundary

Results:

Eighteen patients were included in the study (mean age 66.9±9.03 years); only one patient did not show up for the final visit. Eleven evaluations by investigators were in favor of Blephapad (A), 2 in favor of standard treatment (B), and 4 indicated no treatment difference (C). At the final visit, the total score of the grading scales for MGD improved 38.5% in eyes treated with Blephapad and 30% in eyes treated with standard treatment; out of the 18 patients enrolled, 17 subjects expressed a preference, 70,6% in favor of Blephapad and 29.4% in favor of standard treatment

Conclusions:

In this study Blephapad treatment revealed more effective than standard treatment. As far as safety is concerned, no adverse events related to the treatment was recorded, indicating its absolute safety of use. In addition, the sequential analysis offered important advantages over usual statistical procedures with fixed sample size: the analysis of the data as it comes in and a reduction in the amount of data to be collected to reach statistically valid conclusions and the greater the difference between treatments, the fewer the patients are needed to achieve statistically significance

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a competing company