An interventional study of Blephapad Combo and Standard treatment in Bilateral Blepharitis (Disorder), sponsored by NTC srl. Completed at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by NTC srl · Not applicable, Interventional, and Treatment
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →NTC srl is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Combination Product: Blephapad Combo
Wet, warm gauze twice daily for one month.
Other: Standard treatment
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, 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)
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
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)
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)
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)
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)
Patients were enrolled between May 2017 and January 2018 at the Ophthalmology Unit of the Magna Graecia University of Catanzaro in Italy
| Milestone | Study Treatment | Standard Treatment |
|---|---|---|
| Started | 19 | 19 |
| Completed | 18 | 18 |
| Not completed | 1 | 1 |
| Withdrew: Suspected colon cancer | 1 | 1 |
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.
| percentage of change in the total score | Study Treatment | Standard Treatment |
|---|---|---|
| Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) | -38.5 ± 21.3 | -29.9 ± 17.6 |
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.
| Participants | Study Treatment | Standard Treatment |
|---|---|---|
| Eye improved | 16 | 15 |
| Eye NOT improved | 1 | 2 |
| Missing | 1 | 1 |
At the end of study patients was asked to state their preference on the treatments used.
| Participants | Study Treatment | Standard Treatment |
|---|---|---|
| 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 | 5 |
A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study
| Participants | Study Treatment | Standard Treatment |
|---|---|---|
| Eyes with Serious Ocular Adverse Event | 0 | 0 |
| Eyes with Ocular Adverse Event | 8 | 7 |
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.
| percentage of Application (Wet Wipes) | Study Treatment | Standard Treatment |
|---|---|---|
| Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes | 96.1 ± 8.8 | 94.2 ± 9.5 |
Collected over from baseline to week 4. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Treatment | 0/18 (0%) | 0/18 (0%) | 8/18 (44.4%) |
| Standard Treatment | 0/18 (0%) | 0/18 (0%) | 7/18 (38.9%) |
| Event | Study Treatment | Standard Treatment |
|---|---|---|
| Ocular painEye disorders | 4/18 | 2/18 |
| Dry eyeEye disorders | 3/18 | 3/18 |
| Itching or discomfortEye disorders | 3/18 | 2/18 |
| IrritationEye disorders | 2/18 | 2/18 |
| Increased lacrimationEye disorders | 2/18 | 1/18 |
| Ocular hyperaemiaEye disorders | 2/18 | 1/18 |
| Conjunctival hyperaemiaEye disorders | 1/18 | 1/18 |
| Ocular secretionsEye disorders | 1/18 | 1/18 |
| Crusts on eyelid marginsEye disorders | 1/18 | 1/18 |
| Blurred visionEye disorders | 1/18 | 0/18 |
Patients aged \> 40 years with symmetrical bilateral posterior blepharitis. Each eye represented a single experimental unit.
| Age, Categorical(Participants) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 13 | 13 | 26 |
| Age, Continuous(years) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| Mean | 66.9 ± 9.03 | 66.9 ± 9.03 | 66.9 ± 9.03 |
| Sex: Female, Male(Participants) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 18 | 18 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| Italy | 18 | 18 | 18 |
| Meibomian Gland Dysfunction (MGD) at baseline (visit 2)(score on a scale) | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| Mean | 9.17 ± 2.64 | 9.39 ± 2.73 | 9.28 ± 2.65 |
PDFs hosted by the registry, ClinicalTrials.gov.
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