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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03301844
Enrollment
19
Registered
2017-10-04
Start date
2017-05-15
Completion date
2018-02-09
Last updated
2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Blepharitis (Disorder)

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.

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.

Interventions

COMBINATION_PRODUCTBlephapad 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.

OTHERStandard treatment

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

Sponsors

NTC srl
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A randomized, controlled study with a closed sequential design

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)from baseline to week 4The 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

MeasureTime frameDescription
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

MeasureTime frameDescription
Incidence of Ocular Adverse Events Reported Throughout the StudyFrom 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 EyesFrom 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.

Countries

Italy

Participant flow

Recruitment details

Patients were enrolled between May 2017 and January 2018 at the Ophthalmology Unit of the Magna Graecia University of Catanzaro in Italy

Pre-assignment details

During a 2-week run-in period starting at Visit 1, and after the patient has provided informed consent, the Investigator will collect demographic data and medical history and perform a physical examination of the patient.

Participants by arm

ArmCount
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. 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.
18
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. 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.
18
Standard Treatment
Wet, warm gauze twice daily for one month. Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
18
Standard Treatment
Wet, warm gauze twice daily for one month. Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
18
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studysuspected colon cancer11

Baseline characteristics

CharacteristicStudy TreatmentStandard TreatmentTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants13 Participants26 Participants
Age, Categorical
Between 18 and 65 years
5 Participants5 Participants10 Participants
Age, Continuous66.9 years
STANDARD_DEVIATION 9.03
66.9 years
STANDARD_DEVIATION 9.03
66.9 years
STANDARD_DEVIATION 9.03
Meibomian Gland Dysfunction (MGD) at baseline (visit 2)9.17 score on a scale
STANDARD_DEVIATION 2.64
9.39 score on a scale
STANDARD_DEVIATION 2.73
9.28 score on a scale
STANDARD_DEVIATION 2.65
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants18 Participants36 Participants
Region of Enrollment
Italy
18 participants18 participants18 participants
Sex: Female, Male
Female
9 Participants9 Participants18 Participants
Sex: Female, Male
Male
9 Participants9 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 18
other
Total, other adverse events
8 / 187 / 18
serious
Total, serious adverse events
0 / 180 / 18

Outcome results

Primary

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.

Time frame: from baseline to week 4

Population: patients with symmetrical bilateral posterior blepharitis

ArmMeasureValue (MEAN)Dispersion
Study TreatmentPercentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)-38.5 percentage of change in the total scoreStandard Deviation 21.3
Standard TreatmentPercentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)-29.9 percentage of change in the total scoreStandard Deviation 17.6
Secondary

Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)

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.

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)

Population: Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Study TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Eye improved16 Participants
Study TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Eye NOT improved1 Participants
Study TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Missing1 Participants
Standard TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Eye improved15 Participants
Standard TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Eye NOT improved2 Participants
Standard TreatmentChange of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)Missing1 Participants
Secondary

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

Time frame: at Visit 3 (week 4)

Population: Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint. One patient didn't express the preference therefore 17 patients were considered.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study TreatmentNumber of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)12 Participants
Standard TreatmentNumber of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)5 Participants
p-value: 0.071Chi-squared
Other Pre-specified

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

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.

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)

Population: Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.

ArmMeasureValue (MEAN)Dispersion
Study TreatmentCompliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes96.1 percentage of Application (Wet Wipes)Standard Deviation 8.8
Standard TreatmentCompliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes94.2 percentage of Application (Wet Wipes)Standard Deviation 9.5
Other Pre-specified

Incidence of Ocular Adverse Events Reported Throughout the Study

A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study

Time frame: From Visit 2 (baseline) to Visit 3 (week 4)

Population: Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.~One patient reported a treatment-emergent systemic adverse event, i.e. Suspected colon cancer of mild severity that led to permanent treatment discontinuation.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Study TreatmentIncidence of Ocular Adverse Events Reported Throughout the StudyEyes with Serious Ocular Adverse Event0 Participants
Study TreatmentIncidence of Ocular Adverse Events Reported Throughout the StudyEyes with Ocular Adverse Event8 Participants
Standard TreatmentIncidence of Ocular Adverse Events Reported Throughout the StudyEyes with Serious Ocular Adverse Event0 Participants
Standard TreatmentIncidence of Ocular Adverse Events Reported Throughout the StudyEyes with Ocular Adverse Event7 Participants
p-value: 0.7353Chi-squared

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026