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

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.

• 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) [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) [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: 1. Eye on Blephapad Combo: Improved-Eye on Standard: Improved 2. Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved 3. Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved 4. 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 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 [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 [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.

Sex: All, ages: 40 Years to any

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

Participant flow

Outcome results

• Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) (Primary), Mean, percentage of change in the total score: Study Treatment -38.5 +/- 21.3; Standard Treatment -29.9 +/- 17.6
• Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) (Secondary), Count of participants, Participants: Study Treatment 16; Standard Treatment 15
• 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) (Secondary), Count of participants, Participants: Study Treatment 12; Standard Treatment 5 (p 0.071)
• Incidence of Ocular Adverse Events Reported Throughout the Study (Other pre specified), Count of participants, Participants: Study Treatment 0; Standard Treatment 0 (p 0.7353)
• Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes (Other pre specified), Mean, percentage of Application (Wet Wipes): Study Treatment 96.1 +/- 8.8; Standard Treatment 94.2 +/- 9.5

Adverse events

Time frame: from baseline to week 4

Other adverse events by term

• Results publication: 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 30929188

• Study Protocol and Statistical Analysis Plan (PDF, 2017-01-19)

• Vincenzo Scorcia, Principal investigator, A.O.U. Policlinico Mater Domini