Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis

Study Overview
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Brief Summary
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Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).

Detailed Description
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Antibiotic/steroid combination compared to individuals components 8 days of treatment.

Official Title
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An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacterial Ocular Inflammation and Infection (Blepharitis and/or Keratitis and/or Conjunctivitis)

Conditions
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Blepharitis, Conjunctivitis, Keratitis

Intervention / Treatment
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* Drug: Moxifloxacin and Dexamethasone combined
* Drug: Moxifloxacin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis Exclusion Criteria: Uncontrolled glaucoma or intraocular hypertension Wear contact lens during the study Patients with sight in a single eye Suspicious of viral, fungic infection Use of any other ophthalmic drugs during the study Use of immunosuppressant therapy Known or suspected allergy or hypersensibility to any component of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>antibiotic /steroid combination compared with individual administration of steroid and antibiotic | Drug: Moxifloxacin<br>* moxifloxacin 0,5% qid and<br>* Other names: maxidex and vigamox;Drug: Dexamethasone<br>* dexamethasone 0,1% qid<br>|
| Experimental: 1<br>combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication | Drug: Moxifloxacin and Dexamethasone combined<br>* moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined<br>* Other names: vigadexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8) |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis |  | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxifloxacin, dexamethasone, ocular inflammation, ocular infection