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

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ClinicalTrials.gov Identifier: NCT03301844
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
NTC srl

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.

Condition or disease Intervention/treatment Phase
Bilateral Blepharitis (Disorder) Combination Product: Blephapad Combo Other: Standard treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A randomized, controlled study with a closed sequential design
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Arm Intervention/treatment
Experimental: 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.
Combination Product: 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.


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




Primary Outcome Measures :
  1. Percentage change of the total score of the Grading Scales for Meibomian Gland Dysfunction [ Time Frame: from baseline to week 4 ]
    Percentage change (assessed at week 4) of the total score of the Grading Scales for Meibomian Gland Dysfunction applied to photographic images of different aspects (e.g. lid margin findings of vascularity, plugging of gland orifices, etc.) of the experimental unit (eye)


Secondary Outcome Measures :
  1. 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) ]
    Change (assessed at week 3) of the total score of the Grading Scales for Meibomian Gland Dysfunction

  2. 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: From Visit 2 (baseline) to Visit 3 (week 4) ]
    At the end of study patients will be asked to state their preference on the treatments used


Other Outcome Measures:
  1. Incidence of ocular and systemic adverse events reported throughout the study [ Time Frame: From Visit 2 (baseline) to Visit 3 (week 4) ]
    A targeted physical examination will be performed at all visits and monitoring for ocular and systemic adverse events will occur throughout the study

  2. 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 will be evaluated by counting the applications of treatment (wet wipes) to each eyes, as reported in the patient diary



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301844


Locations
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Italy
A.O.U. Policlinico Mater Domini
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
NTC srl
Investigators
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Principal Investigator: Vincenzo Scorcia A.O.U. Policlinico Mater Domini
  Study Documents (Full-Text)

Documents provided by NTC srl:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NTC srl
ClinicalTrials.gov Identifier: NCT03301844     History of Changes
Other Study ID Numbers: BLEPHA 01-2017
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases