NCT03301844

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

Completed NA Results posted Last updated 19 December 2019

What this trial tests

NA trial testing Blephapad Combo in Bilateral Blepharitis (Disorder) in 19 participants. Completed in 9 February 2018.

Timeline

15 May 2017

Primary endpoint
9 February 2018

9 February 2018

Quick facts

Lead sponsor	NTC srl
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	15 May 2017
Primary completion	9 February 2018
Estimated completion	9 February 2018
Sites	1 location across Italy

Drugs / interventions tested

• Blephapad Combo
• Standard treatment

Conditions studied

• Bilateral Blepharitis (Disorder) — all drugs for Bilateral Blepharitis (Disorder) →

Sponsor

NTC srl — full company profile →

Who can join

40 and older, any sex, with Bilateral Blepharitis (Disorder). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) Primary · 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 t

Group	Value	95% CI
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 · 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, Li

Group	Value	95% CI
Study Treatment	16
Standard Treatment	15
Study Treatment	1
Standard Treatment	2
Study Treatment	1
Standard Treatment	1

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 · at Visit 3 (week 4)

At the end of study patients was asked to state their preference on the treatments used.

Group	Value	95% CI
Study Treatment	12
Standard Treatment	5

Incidence of Ocular Adverse Events Reported Throughout the Study Secondary · 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

Eyes with Serious Ocular Adverse Event

Group	Value	95% CI
Study Treatment	0
Standard Treatment	0

Eyes with Ocular Adverse Event

Group	Value	95% CI
Study Treatment	8
Standard Treatment	7

Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes Secondary · 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.

Group	Value	95% CI
Study Treatment	96.1	± 8.8
Standard Treatment	94.2	± 9.5

Adverse events — posted to ClinicalTrials.gov

Time frame: from baseline to week 4. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Treatment

Serious: 0/18 (0%)

Deaths: 0/18

Standard Treatment

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (12 terms — click to expand)

Reaction	System	Study Treatment	Standard Treatment
Ocular pain	Eye disorders	—	—
Dry eye	Eye disorders	—	—
Itching or discomfort	Eye disorders	—	—
Irritation	Eye disorders	—	—
Increased lacrimation	Eye disorders	—	—
Ocular hyperaemia	Eye disorders	—	—
Conjunctival hyperaemia	Eye disorders	—	—
Ocular secretions	Eye disorders	—	—
Crusts on eyelid margins	Eye disorders	—	—
Blurred vision	Eye disorders	—	—
Purulent discharge	Eye disorders	—	—
Madarosis	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03301844 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and Safety of Wet Wipes Containing Hy-Ter^® Solution Compared with Standard Care for Bilateral Posterior Blepharitis: A Preliminary Randomized Controlled Study.
   De Luca V, Carnevali A, Carnovale Scalzo G, Piccoli G, et al · · 2019 · cited 5× · PMID 30929188 · DOI 10.1007/s40123-019-0182-x