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

Novelty. Technology. Care. (NTC)

Status: Completed

Conditions: Bilateral Blepharitis (Disorder)

Treatments: Combination Product: Blephapad Combo; Other: Standard treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301844

BLEPHA 01-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Study treatment

Experimental group

Description:

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.

Treatment:

Combination Product: Blephapad Combo

Standard treatment

Other group

Description:

Wet, warm gauze twice daily for one month.

Treatment:

Other: Standard treatment