Clinical trial NCT03301844: To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Blepharitis (Disorder)
Lead sponsor: NTC srl
Sponsor class: INDUSTRY
First posted: 2017-10-04
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A randomized, controlled study with a closed sequential design
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
timeFrame: from baseline to week 4
Secondary outcomes:
measure: Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
timeFrame: From Visit 2 (baseline) to Visit 3 (week 4)
measure: 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)
timeFrame: at Visit 3 (week 4)
Other outcomes:
measure: Incidence of Ocular Adverse Events Reported Throughout the Study
timeFrame: From Visit 2 (baseline) to Visit 3 (week 4)
measure: Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes
timeFrame: From Visit 2 (baseline) to Visit 3 (week 4)
Locations:
city: Catanzaro
country: Italy
facility: A.O.U. Policlinico Mater Domini
state: CZ
Study officials:
affiliation: A.O.U. Policlinico Mater Domini
name: Vincenzo Scorcia
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Luca V, Carnevali A, Carnovale Scalzo G, Piccoli G, Bruzzichessi D, Scorcia V. Efficacy and Safety of Wet Wipes Containing Hy-Ter(R) Solution Compared with Standard Care for Bilateral Posterior Blepharitis: A Preliminary Randomized Controlled Study. Ophthalmol Ther. 2019 Jun;8(2):313-321. doi: 10.1007/s40123-019-0182-x. Epub 2019 Mar 30.