N/A
N=38
To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis
Bilateral Blepharitis (Disorder)
Bottom Line
View on ClinicalTrials.gov: NCT03301844 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) — -38.5; -29.9 percentage of change in the total score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blephapad Combo (Combination_product); Standard treatment (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- NTC srl
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD) |
-38.5; -29.9 | — |
| SECONDARY Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved) |
16; 15; 1; 2; 1; 1 | — |
| 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) |
12; 5 | 0.071 |
Summary
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03301844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.