Bilateral Blepharitis (Disorder)NCT03301844
To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis
A study testing Blephapad Combo and Standard treatment in people with Bilateral Blepharitis (Disorder), run by NTC srl at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bilateral Blepharitis (Disorder)
- What is being tested?
- Blephapad Combo and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2017to 9 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years
- Male or female
- Diagnosis of bilateral posterior blepharitis
- Written informed consent of patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.
Read the 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.
- Conditions
- Bilateral Blepharitis (Disorder)
- Being tested
- Blephapad Combo, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blephapad ComboCombination 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.
Standard treatmentOther
Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Blephapad Combo |
| Standard treatment | Other | Wet, warm gauze twice daily for one month. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to week 4
Secondary outcomes (2)
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:
- Eye on Blephapad Combo: Improved-Eye on Standard: Improved
- Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved
- Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved
- 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.
Measured: 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.
Measured: at Visit 3 (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start15 May 2017
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bilateral Blepharitis (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A randomized, controlled study with a closed sequential design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NTC srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincenzo Scorcia, Principal investigator, A.O.U. Policlinico Mater Domini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301844
- Sponsor's protocol ID
- BLEPHA 01-2017
- Status last verified
- Nov 2019
- First submitted
- 2 Aug 2017
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30929188
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03301844
- Acronym / sponsor ID
- BLEPHA 01-2017
- Conditions
- Bilateral Blepharitis (Disorder)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NTC srlIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, controlled study with a closed sequential design
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Combination Product: Blephapad ComboBlephapad 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 | Other: Standard treatmentWet, warm gauze twice daily for one month. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 40 years
- Male or female
- Diagnosis of bilateral posterior blepharitis
- Written informed consent of patient
Key exclusion criteria (8 listed)
- Treatment with topical ophthalmic drugs (artificial tears allowed)
- Ocular surgery in the previous 6 months
- Pregnant or breastfeeding women
- Alcohol abuse
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blephapad ComboBlephapad 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. | Combination product | Study treatment |
| Standard treatmentStandard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze. | Other | Standard treatment |
Primary outcome
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
Time frame: 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 total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.
2 secondary outcomes
Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
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)
Time frame: at Visit 3 (week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30929188De 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Scorcia principal investigator
A.O.U. Policlinico Mater Domini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blephapad Combo and Standard treatment in people with Bilateral Blepharitis (Disorder), run by NTC srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) (time frame: from baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.