Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of… (NCT01721694) | Clinical Trial Compass
WithdrawnPhase 3
Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection
Stopped: withdrawn by industry
Brazil0Started 2012-12
Plain-language summary
To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).
Who can participate
Age range18 Years
SexALL
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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 with or without bacterial involvement corneal by biomicroscopy, with positive staining corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit
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 is contraindicated.
* Use of any topical ophthalmic medications preserved during study participation. Not be allowed eyedrops preserved (eg artificial tears).
* Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior to study entry.
* Use of systemic steroids within 14 days prior to study entry. Ophthalmic topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week before admission to the study. Will not be allowed to use these medications during study participation. Will not be allowed to use nasal steroids during the study. Will be allowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermal topics.
* Use of n…