Dataset Information

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %).

ABSTRACT:

Background

Bibrocathol is a well-established antiseptic drug for the treatment of acute eyelid diseases like blepharitis. Despite its frequent use in clinical practice, no controlled clinical trial on the efficacy of bibrocathol 2% eye ointment has been performed until now. The aim of the study was to investigate efficacy, safety and tolerability of bibrocathol (Posiformin® 2 %) eye ointment in patients diagnosed with blepharitis.

Methods

In this multi-center, randomized, double-masked, placebo-controlled parallel-group comparison, the change of signs and symptoms (sum score) of blepharitis in 197 patients (ITT (intention-to-treat-group); mean age 56?±?18 years, 56 % female, active drug:vehicle?=?97:100) over 2 weeks treatment with bibrocathol 2 % eye ointment was evaluated.

Results

Patients receiving bibrocathol 2 % showed greater improvement in the sum score than the placebo patients (p?ConclusionsBlepharitis therapy with the antiseptic bibrocathol 2 % in this trial was highly efficacious and safe.

SUBMITTER: Bezdetko PA

PROVIDER: S-EPMC3501175 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Publications

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %).

Bezdetko Pavel A PA Sergienko Nikolai N Dyomin Yuriy Y Korol Andrei A Nikitin Nik N Merzbacher Matthias M Groß Dorothea D Kohnen Ralf R

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 20120425 12

<h4>Background</h4>Bibrocathol is a well-established antiseptic drug for the treatment of acute eyelid diseases like blepharitis. Despite its frequent use in clinical practice, no controlled clinical trial on the efficacy of bibrocathol 2% eye ointment has been performed until now. The aim of the study was to investigate efficacy, safety and tolerability of bibrocathol (Posiformin® 2 %) eye ointment in patients diagnosed with blepharitis.<h4>Methods</h4>In this multi-center, randomized, double-m ...[more]

PMID: 22527308

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Project description:INTRODUCTION:A novel treatment for posterior blepharitis which involves the use of disposable wet wipes imbibed with a solution of terpinen-4-ol and hyaluronic acid (Hy-Ter®) as well as aloe, natural anti-inflammatories and antiseptics (Blephapad Combo; Novelty Technology Care, Milan, Italy) has been proposed. The aim of this study was to compare the efficacy and safety of treatment with Blephapad Combo with standard treatment. METHODS:We conducted 4-week, open-label, randomized controlled study with a closed sequential design at the Magna Graecia University of Catanzaro, Italy in which patients aged > 40 years with symmetrical bilateral posterior blepharitis were enrolled. Each eye represented a single experimental unit. Patients were randomly assigned using a computer-generated randomization list to apply a reusable heated compress to the eyelid of one eye before cleansing the eyelid with the Blephapad Combo wet wipe (Blephapad Combo treatment arm) or to use the standard treatment of applying a wet and warm gauze to the other eye (standard treatment arm), twice daily for 4 weeks. The primary endpoint was the percentage change from baseline to week 4 in meibomian gland dysfunction (MGD) grading scale scores. RESULTS:Eighteen patients (9 men; 9 women) with a mean (± standard deviation) age of 66.9 ± 9.03 years were included in the study. Compared with the eye receiving the standard treatment, treatment with Blephapad Combo appeared to improve the MGD total score after 4 weeks of treatment (mean change from baseline - 29.9 vs. - 38.5%). The assessment of the investigators was that in 11 patients the eye treated with Blephapad Combo showed greater benefit, in two patients the eye treated with the standard treatment showed greater benefit and in four patients there was no difference between treatments. Blephapad Combo was well tolerated, with no serious adverse events (AEs) reported. Minor ocular AEs were reported in 44.4 and 38.9% of patients in the Blephard Combo and standard treatment arms, respectively. CONCLUSIONS:Treatment with Blephapad Combo was more effective than the standard treatment in ameliorating MGD in patients with posterior blepharitis. Minor ocular AEs events were equally distributed between the two treatments arms. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03301844.

Project description:Background Identification of patients at risk of tuberculosis relapse following treatment would revolutionize clinical trials of new drugs and regimens and facilitate clinical management. The study aim was to determine whether tuberculosis patients who subsequently suffer relapse have different immune responses to mycobacteria in vitro compared to patients who remain cured for two years post-treatment. Methods First episode pulmonary tuberculosis patients were recruited into a surrogate marker study in Cape Town, South Africa. Peripheral blood samples were collected at diagnosis and after two and four weeks of tuberculosis treatment. Diluted blood was cultured with live Mycobacterium tuberculosis for six days and cellular RNA was frozen. Gene expression in samples from ten patients who subsequently relapsed, confirmed by stain genotyping, was compared to those who remained cured using Affymetrix microarrays. Results At diagnosis, the expression of 668 genes was significantly different in samples from patients who subsequently relapsed compared to successfully cured patients, and these differences persisted for at least four weeks. Gene Ontology and biological pathways analyses revealed the most significant difference was up-regulation of genes involved in cytotoxic cell-mediated killing, such as perforin, granulysin and fas ligand. Results were confirmed by qRT-PCR in a wider patient cohort. Conclusions These data show that patients who will subsequently relapse exhibit altered immune responses at diagnosis, including excessively robust cytolytic responses to M. tuberculosis in vitro, compared to patients who will achieve durable cure. Together with microbiological and clinical indices, these differences could be exploited for patient stratification in drugs trials, or for host-directed therapy development. Venous blood samples were diluted in culture medium and stimulated with live M. tuberculosis for 6 days. Samples from 10 TB patients who subsequently relapsed and 10 patients whore remained disease-free for 2 years. Samples collected at TB diagnosis and after 2 weeks or 4 weeks of treatment of first TB episode.

Dataset Information

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %).

Background

Methods

Results

Publications

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %).

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