To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis
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.
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2018
CompletedResults Posted
Study results publicly available
December 19, 2019
CompletedDecember 19, 2019
November 1, 2019
9 months
August 2, 2017
September 10, 2019
November 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
from baseline to week 4
Secondary Outcomes (2)
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
From Visit 2 (baseline) to Visit 3 (week 4)
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 Visit 3 (week 4)
Other Outcomes (2)
Incidence of Ocular Adverse Events Reported Throughout the Study
From Visit 2 (baseline) to Visit 3 (week 4)
Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes
From Visit 2 (baseline) to Visit 3 (week 4)
Study Arms (2)
Study treatment
EXPERIMENTALBlephapad 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.
Standard treatment
OTHERWet, warm gauze twice daily for one month.
Interventions
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, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
Eligibility Criteria
You may qualify if:
- Age \> 40 years
- Male or female
- Diagnosis of bilateral posterior blepharitis
- Written informed consent of patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NTC srllead
Study Sites (1)
A.O.U. Policlinico Mater Domini
Catanzaro, CZ, 88100, Italy
Related Publications (1)
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.
PMID: 30929188DERIVED
Results Point of Contact
- Title
- Alessandro Colombo
- Organization
- NTC srl
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo Scorcia
A.O.U. Policlinico Mater Domini
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2017
First Posted
October 4, 2017
Study Start
May 15, 2017
Primary Completion
February 9, 2018
Study Completion
February 9, 2018
Last Updated
December 19, 2019
Results First Posted
December 19, 2019
Record last verified: 2019-11