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

NCT ID: NCT03301844

Last Updated: 2019-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-02-09

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.

Conditions

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Bilateral Blepharitis (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A randomized, controlled study with a closed sequential design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study treatment

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.

Group Type EXPERIMENTAL

Blephapad Combo

Intervention Type COMBINATION_PRODUCT

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.

Standard treatment

Wet, warm gauze twice daily for one month.

Group Type OTHER

Standard treatment

Intervention Type OTHER

Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.

Interventions

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Blephapad Combo

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.

Intervention Type COMBINATION_PRODUCT

Standard treatment

Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NTC srl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincenzo Scorcia

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Policlinico Mater Domini

Locations

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A.O.U. Policlinico Mater Domini

Catanzaro, CZ, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30929188 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BLEPHA 01-2017

Identifier Type: -

Identifier Source: org_study_id