To Compare Blephapad Combo vs Standard… | Clinical Trial

Key information

Conditions

Bilateral Blepharitis (Disorder)

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U. Policlinico Mater Domini

Catanzaro, CZ, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blephapad Combo

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

Other

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

Primary outcomes

Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)

Time frame: from baseline to week 4

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.

Secondary outcomes

Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)
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.
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)

Time frame: at Visit 3 (week 4)

At the end of study patients was asked to state their preference on the treatments used.

Other outcomes

Incidence of Ocular Adverse Events Reported Throughout the Study

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)

A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study
Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)

Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.

The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:

(Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the "given wipes/gauze" were 60 and the "expected number of wipes/gauze used" were 2 per days per 4 weeks = 56.

Sponsors and collaborators

Lead sponsor

NTC srl

Industry

Registry information

Official study 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.

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 4, 2017
Registry last updated: Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.