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

Primary Purpose

Bilateral Blepharitis (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blephapad Combo
Standard treatment
Sponsored by
NTC srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Blepharitis (Disorder)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • A.O.U. Policlinico Mater Domini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study treatment

Standard treatment

Arm 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.

Wet, warm gauze twice daily for one month.

Outcomes

Primary Outcome Measures

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

Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
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)
At the end of study patients was asked to state their preference on the treatments used.

Full Information

First Posted
August 2, 2017
Last Updated
November 29, 2019
Sponsor
NTC srl
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1. Study Identification

Unique Protocol Identification Number
NCT03301844
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NTC srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Blepharitis (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A randomized, controlled study with a closed sequential design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study treatment
Arm Type
Experimental
Arm 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.
Arm Title
Standard treatment
Arm Type
Other
Arm Description
Wet, warm gauze twice daily for one month.
Intervention Type
Combination Product
Intervention Name(s)
Blephapad Combo
Intervention Description
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
Other
Intervention Name(s)
Standard treatment
Intervention Description
Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
Primary Outcome Measure Information:
Title
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
Description
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.
Time Frame
from baseline to week 4
Secondary Outcome Measure Information:
Title
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
Description
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.
Time Frame
From Visit 2 (baseline) to Visit 3 (week 4)
Title
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)
Description
At the end of study patients was asked to state their preference on the treatments used.
Time Frame
at Visit 3 (week 4)
Other Pre-specified Outcome Measures:
Title
Incidence of Ocular Adverse Events Reported Throughout the Study
Description
A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study
Time Frame
From Visit 2 (baseline) to Visit 3 (week 4)
Title
Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes
Description
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.
Time Frame
From Visit 2 (baseline) to Visit 3 (week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Scorcia
Organizational Affiliation
A.O.U. Policlinico Mater Domini
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.U. Policlinico Mater Domini
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30929188
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.
Results Reference
derived

Learn more about this trial

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

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