Bilateral Blepharitis (Disorder)
Conditions
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
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.
Sponsors
Study design
Intervention model description
A randomized, controlled study with a closed sequential design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular Adverse Events Reported Throughout the Study | From 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 Eyes | From 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
| Arm | Count |
|---|---|
| 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 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | suspected colon cancer | 1 | 1 |
Baseline characteristics
| Characteristic | Study Treatment | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 66.9 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 36 Participants |
| Region of Enrollment Italy | 18 participants | 18 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 8 / 18 | 7 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Treatment | 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 |
| Standard Treatment | Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) | -29.9 percentage of change in the total score | Standard Deviation 17.6 |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Eye improved | 16 Participants |
| Study Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Eye NOT improved | 1 Participants |
| Study Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Missing | 1 Participants |
| Standard Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Eye improved | 15 Participants |
| Standard Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Eye NOT improved | 2 Participants |
| Standard Treatment | Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) | Missing | 1 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 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 Participants |
| 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) | 5 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Treatment | Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes | 96.1 percentage of Application (Wet Wipes) | Standard Deviation 8.8 |
| Standard Treatment | Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes | 94.2 percentage of Application (Wet Wipes) | Standard Deviation 9.5 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Treatment | Incidence of Ocular Adverse Events Reported Throughout the Study | Eyes with Serious Ocular Adverse Event | 0 Participants |
| Study Treatment | Incidence of Ocular Adverse Events Reported Throughout the Study | Eyes with Ocular Adverse Event | 8 Participants |
| Standard Treatment | Incidence of Ocular Adverse Events Reported Throughout the Study | Eyes with Serious Ocular Adverse Event | 0 Participants |
| Standard Treatment | Incidence of Ocular Adverse Events Reported Throughout the Study | Eyes with Ocular Adverse Event | 7 Participants |