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| ID | Type | Description | Link |
|---|---|---|---|
| S67-OPH-081 | |||
| S67-OPH-081 | Other Identifier | RPS Germany |
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This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.
Reduction of signs and symptoms of blepharitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posiformin 2 % | Active Comparator | Eye ointment applied to the eye lid |
|
| Placebo | Placebo Comparator | corresponding vehicle, eye ointment applied to the eye lid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posiformin 2 %, bibrocathol | Drug | A strip of 5 mm eye ointment applied 3 times per day to the eye lid |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis | Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blepharitis signs and symptoms | Changes between baseline and end of treatment in lid edema, lid erythema, debris, pouting of meibomian glands, ocular discomfort, antiseptic effect | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel A Bezdetko, Prof. | Kharkov District Clinical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kharkov District Clinical Hospital | Kharkiv | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22527308 | Derived | Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25. |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C006748 | bibrocathol |
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| Placebo Comparator | Drug | corresponding vehicle, eye ointment applied to the eye lid |
|