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
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Blepharitis (Disorder)||Combination Product: Blephapad Combo Other: Standard treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||A randomized, controlled study with a closed sequential design|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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)
- 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
- 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
- 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
- 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
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
|A.O.U. Policlinico Mater Domini|
|Catanzaro, CZ, Italy, 88100|
|Principal Investigator:||Vincenzo Scorcia||A.O.U. Policlinico Mater Domini|