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

Sponsor

Adapt Produtos Oftalmológicos Ltda. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01721694

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

May 1, 2013

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Clinical cure [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 [Day 8]
Success obtained with microbiological irradication of pathogens present at baseline

Other Outcome Measures

ophthalmic evaluation [Day 4 and Day 8]
decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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