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

This study has been withdrawn prior to enrollment.
(withdrawn by industry)
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda. Identifier:
First received: November 2, 2012
Last updated: December 10, 2014
Last verified: December 2014
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).

Condition Intervention Phase
Ocular Inflammation
Infection Associated Blepharitis
Conjunctivitis, Bacterial
Drug: azithromycin 1.5%/Loteprednol 0,5% + placebo
Drug: azithromycin 1.5% + Loteprednol 0,5% (separately)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: Day 8 ]
    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)

Secondary Outcome Measures:
  • irradication of pathogens [ Time Frame: Day 8 ]
    Success obtained with microbiological irradication of pathogens present at baseline

Other Outcome Measures:
  • ophthalmic evaluation [ Time Frame: Day 4 and Day 8 ]
    decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: azithromycin 1.5% + Loteprednol 0,5% eye drops (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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01721694

Department of Ophthalmology of Hospital São Paulo
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Principal Investigator: Rubens Belfort Jr., MD Federal University of São Paulo / Hospital São Paulo
  More Information

Responsible Party: Adapt Produtos Oftalmológicos Ltda. Identifier: NCT01721694     History of Changes
Other Study ID Numbers: AZILOT-12
131.835 ( Other Identifier: CEP-UNIFESP-Plataforma Brasil )
Study First Received: November 2, 2012
Last Updated: December 10, 2014

Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
bacterial ocular inflammation

Additional relevant MeSH terms:
Communicable Diseases
Conjunctivitis, Bacterial
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Eyelid Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Loteprednol Etabonate
Ophthalmic Solutions
Anti-Allergic Agents
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on May 22, 2017