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

Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection

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).

Study Overview

• Status: Withdrawn
• Conditions: Ocular Inflammation; Keratitis; Conjunctivitis, Bacterial; Infection Associated Blepharitis
• Intervention / Treatment: Drug: azithromycin 1.5%/Loteprednol 0,5% + placebo; Drug: azithromycin 1.5% + Loteprednol 0,5% (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)

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-062
    • Department of Ophthalmology of Hospital São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: azithromycin 1.5%/Loteprednol 0,5% + placebo; fixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops	Drug: azithromycin 1.5%/Loteprednol 0,5% + placebo; 1 drop, AO, QID
ACTIVE_COMPARATOR: azithromycin 1.5% + Loteprednol 0,5% (separately); azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)	Drug: azithromycin 1.5% + Loteprednol 0,5% (separately); 1 drop, QID, AO; Other Names: azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure	Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
irradication of pathogens	Success obtained with microbiological irradication of pathogens present at baseline	Day 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ophthalmic evaluation	decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting	Day 4 and Day 8

Collaborators and Investigators

• Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Investigators: Principal Investigator: Rubens Belfort Jr., MD, Federal University of São Paulo / Hospital São Paulo

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2013
• Study Completion (ANTICIPATED): May 1, 2013

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (ESTIMATE): November 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: conjunctivitis; keratitis; blepharitis; bacterial ocular inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Corneal Diseases; Eyelid Diseases; Eye Infections, Bacterial; Eye Infections; Inflammation; Infections; Communicable Diseases; Keratitis; Conjunctivitis; Blepharitis; Conjunctivitis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Anti-Allergic Agents; Loteprednol Etabonate; Azithromycin
• Other Study ID Numbers: AZILOT-12; 131.835 (OTHER: CEP-UNIFESP-Plataforma Brasil)