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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Adapt Produtos Oftalmológicos Ltda.
Sponsor:
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01721694
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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
Keratitis
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Success obtained with microbiological irradication of pathogens present at baseline


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


Estimated Enrollment: 60
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
Other Name: azithromycin 1.5%/Loteprednol 0,5% + placebo
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721694

Contacts
Contact: Cristina Muccioli, MD 5511-99748809 crissmucci@gmail.com
Contact: Luci Silva, MBA 5511-71571967 luci.pesquisa@gmail.com

Locations
Brazil
Department of Ophthalmology of Hospital São Paulo Not yet recruiting
São Paulo, Brazil, 04023-062
Principal Investigator: Rubens Belfort, MD         
Sub-Investigator: Cristina Muccioli, MD         
Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Investigators
Principal Investigator: Rubens Belfort Jr., MD Federal University of São Paulo / Hospital São Paulo
  More Information

No publications provided

Responsible Party: Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier: NCT01721694     History of Changes
Other Study ID Numbers: AZILOT-12, 131.835
Study First Received: November 2, 2012
Last Updated: November 5, 2012
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Eye Infections, Bacterial
Eye Infections
Blepharitis
Conjunctivitis
Conjunctivitis, Bacterial
Inflammation
Keratitis
Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Bacterial Infections
Infection
Pathologic Processes
Corneal Diseases
Tetrahydrozoline
Azithromycin
Loteprednol etabonate
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 24, 2014