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The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | 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. |
|
| Standard treatment | Other | Wet, warm gauze twice daily for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Visit 2 (baseline) to Visit 3 (week 4) |
| Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Scorcia | A.O.U. Policlinico Mater Domini | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Policlinico Mater Domini | Catanzaro | CZ | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30929188 | Derived | 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. |
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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.
Patients were enrolled between May 2017 and January 2018 at the Ophthalmology Unit of the Magna Graecia University of Catanzaro in Italy
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients aged > 40 years with symmetrical bilateral posterior blepharitis. Each eye represented a single experimental unit.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One patient was excluded due to suspected colon cancer. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | patients with symmetrical bilateral posterior blepharitis | Posted | Mean | Standard Deviation | percentage of change in the total score | from baseline to week 4 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Colombo | NTC srl | +39 02 4385 0490 | alessandro.colombo@ntcpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2017 | Aug 1, 2017 | Prot_SAP_000.pdf |
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A randomized, controlled study with a closed sequential design
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|
| Standard treatment | Other | Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze. |
|
| From Visit 2 (baseline) to Visit 3 (week 4) |
| 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. | at 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. |
| From Visit 2 (baseline) to Visit 3 (week 4) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| Count of Participants |
| Participants |
| Participants |
|
| Age, Continuous | One patient was excluded due to suspected colon cancer. | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | One patient was excluded due to suspected colon cancer | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | One patient was excluded due to suspected colon cancer. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | One patient was excluded due to suspected colon cancer. | Number | participants | Participants |
|
| Meibomian Gland Dysfunction (MGD) at baseline (visit 2) | 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 (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. 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. Higher scores implied a worse meibomian gland condition while lower scores were correlated to a better condition. | One patient was excluded due to suspected colon cancer. | Mean | Standard Deviation | score on a scale | 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. |
| OG001 | 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. |
|
|
| 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:
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. | 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. | Posted | Count of Participants | Participants | From Visit 2 (baseline) to Visit 3 (week 4) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | at Visit 3 (week 4) |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | From Visit 2 (baseline) to Visit 3 (week 4) |
|
|
|
|
| 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. | Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye. | Posted | Mean | Standard Deviation | percentage of Application (Wet Wipes) | From Visit 2 (baseline) to Visit 3 (week 4) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 8 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 7 | 18 |
| Ocular pain | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Irritation | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Itching or discomfort | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Increased lacrimation | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Ocular secretions | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Crusts on eyelid margins | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Blurred vision | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Purulent discharge | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Madarosis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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