Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection

Last updated: December 10, 2014
Sponsor: Adapt Produtos Oftalmológicos Ltda.
Overall Status: Trial Not Available

Phase

3

Condition

Blepharitis

Inflammation

Conjunctivitis, Bacterial

Treatment

N/A

Clinical Study ID

NCT01721694
AZILOT-12
131.835
  • Ages > 18
  • All Genders

Study 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).

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 Start date:
December 01, 2012
Estimated Completion Date:
May 31, 2013

Study Description

Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin 1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)

Connect with a study center

  • Department of Ophthalmology of Hospital São Paulo

    São Paulo, 04023-062
    Brazil

    Site Not Available

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