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

NCT ID: NCT01721694

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-05-31

Brief 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).

Detailed 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)

Conditions

Ocular Inflammation; Infection Associated Blepharitis; Keratitis; Conjunctivitis, Bacterial

Keywords

bacterial ocular inflammation; blepharitis; keratitis; conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

azithromycin 1.5%/Loteprednol 0,5% + placebo

fixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops

Group Type: EXPERIMENTAL

azithromycin 1.5%/Loteprednol 0,5% + placebo

Intervention Type: DRUG

1 drop, AO, QID

azithromycin 1.5% + Loteprednol 0,5% (separately)

azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)

Group Type: ACTIVE_COMPARATOR

azithromycin 1.5% + Loteprednol 0,5% (separately)

Intervention Type: DRUG

1 drop, QID, AO

Interventions

azithromycin 1.5%/Loteprednol 0,5% + placebo

1 drop, AO, QID

Intervention Type: DRUG

azithromycin 1.5% + Loteprednol 0,5% (separately)

1 drop, QID, AO

Intervention Type: DRUG

Other Intervention Names

azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)

Eligibility Criteria

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 nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior to study entry or at any time during the study, unless the patient is under treatment regimen with stable (not necessary) for at least 2 months before Admission and therapy continues throughout the study.
• Any disturbance or ocular or systemic disease, complicating factors or structural abnormality that affects the conduct or outcome of the study in a negative way or represents an undue risk to patient safety, according to the opinion of the investigator.
• Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressive therapy (including chemotherapy).
• Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, to steroids or any other component of the study drug;
• Pregnant or lactating. (Women of childbearing age may be admitted if they use contraception and submit urine pregnancy test negative);
• Any patient who has a family member who participates in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adapt Produtos Oftalmológicos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubens Belfort Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo / Hospital São Paulo

Locations

Department of Ophthalmology of Hospital São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

131.835

Identifier Type: OTHER

Identifier Source: secondary_id

AZILOT-12

Identifier Type: -

Identifier Source: org_study_id