Trial Outcomes & Findings for To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis (NCT NCT03301844)

Last Updated: 2019-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

from baseline to week 4

Results posted on

2019-12-19

Participant Flow

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

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.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19 19	19 19
Overall Study COMPLETED	18 18	18 18
Overall Study NOT COMPLETED	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study suspected colon cancer	1	1

Baseline Characteristics

One patient was excluded due to suspected colon cancer.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: from baseline to week 4

Population: patients with symmetrical bilateral posterior blepharitis

Outcome measures

Outcome measures
Measure	Study Treatment n=18 Participants 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.	Standard Treatment n=18 Participants 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.
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)	-38.5 percentage of change in the total score Standard Deviation 21.3	-29.9 percentage of change in the total score Standard Deviation 17.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Study Treatment n=18 Participants 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.	Standard Treatment n=18 Participants 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.
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) Eye improved	16 Participants	15 Participants
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) Eye NOT improved	1 Participants	2 Participants
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) Missing	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Study Treatment n=17 Participants 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.	Standard Treatment n=17 Participants 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.
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)	12 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Study Treatment n=18 Participants 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.	Standard Treatment n=18 Participants 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.
Incidence of Ocular Adverse Events Reported Throughout the Study Eyes with Serious Ocular Adverse Event	0 Participants	0 Participants
Incidence of Ocular Adverse Events Reported Throughout the Study Eyes with Ocular Adverse Event	8 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Study Treatment n=18 Participants 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.	Standard Treatment n=18 Participants 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.
Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes	96.1 percentage of Application (Wet Wipes) Standard Deviation 8.8	94.2 percentage of Application (Wet Wipes) Standard Deviation 9.5

Adverse Events

Study Treatment

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Standard Treatment

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Treatment n=18 participants at risk 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.	Standard Treatment n=18 participants at risk 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.
Eye disorders Dry eye	16.7% 3/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	16.7% 3/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Ocular pain	22.2% 4/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Irritation	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Itching or discomfort	16.7% 3/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Increased lacrimation	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Conjunctival hyperaemia	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Ocular secretions	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Crusts on eyelid margins	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Blurred vision	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	0.00% 0/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Ocular hyperaemia	11.1% 2/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Purulent discharge	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	0.00% 0/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review
Eye disorders Madarosis	0.00% 0/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review	5.6% 1/18 • from baseline to week 4 The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review

Additional Information

Alessandro Colombo

NTC srl

Phone: +39 02 4385 0490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Study Treatment n=18 eyes 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.	Standard Treatment n=18 eyes 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.	Total n=36 eyes Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	5 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	10 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Age, Categorical >=65 years	13 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	13 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	26 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Age, Continuous	66.9 years STANDARD_DEVIATION 9.03 • n=5 Participants • One patient was excluded due to suspected colon cancer.	66.9 years STANDARD_DEVIATION 9.03 • n=7 Participants • One patient was excluded due to suspected colon cancer.	66.9 years STANDARD_DEVIATION 9.03 • n=5 Participants • One patient was excluded due to suspected colon cancer.
Sex: Female, Male Female	9 Participants n=5 Participants • One patient was excluded due to suspected colon cancer	9 Participants n=7 Participants • One patient was excluded due to suspected colon cancer	18 Participants n=5 Participants • One patient was excluded due to suspected colon cancer
Sex: Female, Male Male	9 Participants n=5 Participants • One patient was excluded due to suspected colon cancer	9 Participants n=7 Participants • One patient was excluded due to suspected colon cancer	18 Participants n=5 Participants • One patient was excluded due to suspected colon cancer
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) White	18 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	18 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	36 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=7 Participants • One patient was excluded due to suspected colon cancer.	0 Participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Region of Enrollment Italy	18 participants n=5 Participants • One patient was excluded due to suspected colon cancer.	18 participants n=7 Participants • One patient was excluded due to suspected colon cancer.	18 participants n=5 Participants • One patient was excluded due to suspected colon cancer.
Meibomian Gland Dysfunction (MGD) at baseline (visit 2)	9.17 score on a scale STANDARD_DEVIATION 2.64 • n=32 eyes • One patient was excluded due to suspected colon cancer.	9.39 score on a scale STANDARD_DEVIATION 2.73 • n=16 eyes • One patient was excluded due to suspected colon cancer.	9.28 score on a scale STANDARD_DEVIATION 2.65 • n=48 eyes • One patient was excluded due to suspected colon cancer.