Phase
Condition
Blepharitis
Inflammation
Conjunctivitis, Bacterial
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients were male or female, of any race and age minimum of 18 years.
Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis withor without bacterial involvement corneal by biomicroscopy, with positive stainingcorneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctivalhyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flakingeyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit
Exclusion
Exclusion Criteria:
Intraocular hypertension or uncontrolled glaucoma.
Use of contact lenses during the study.
Capacity unilateral visual only.
Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis)or Acanthamoeba, or any other disease where the use of corticosteroids iscontraindicated.
Use of any topical ophthalmic medications preserved during study participation. Not beallowed eyedrops preserved (eg artificial tears).
Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior tostudy entry.
Use of systemic steroids within 14 days prior to study entry. Ophthalmic topicalsteroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week beforeadmission to the study. Will not be allowed to use these medications during studyparticipation. Will not be allowed to use nasal steroids during the study. Will beallowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermaltopics.
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior tostudy entry or at any time during the study, unless the patient is under treatmentregimen with stable (not necessary) for at least 2 months before Admission and therapycontinues throughout the study.
Any disturbance or ocular or systemic disease, complicating factors or structuralabnormality that affects the conduct or outcome of the study in a negative way orrepresents an undue risk to patient safety, according to the opinion of theinvestigator.
Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressivetherapy (including chemotherapy).
Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, tosteroids or any other component of the study drug;
Pregnant or lactating. (Women of childbearing age may be admitted if they usecontraception and submit urine pregnancy test negative);
Any patient who has a family member who participates in this study
Study Design
Study Description
Connect with a study center
Department of Ophthalmology of Hospital São Paulo
São Paulo, 04023-062
BrazilSite Not Available
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