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Trial record 14 of 19 for:    "Lens Disease" | "Estradiol"

Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients

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ClinicalTrials.gov Identifier: NCT01859702
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Condition or disease Intervention/treatment Phase
Cataract Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Study Start Date : April 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: VIGADEXA
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Other Name: Vigadexa®




Primary Outcome Measures :
  1. Mean Aqueous Humor Concentration of Moxifloxacin [ Time Frame: Day 3 (operative day) ]
    A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.



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

Inclusion Criteria:

  • Requires cataract surgery;
  • Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
  • Able to follow instructions and willing to attend all study visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
  • History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
  • Use of medications, as specified in protocol;
  • Severe dry eye syndrome;
  • Use of contact lenses two days before surgery until the last visit;
  • External eye disease, infection or inflammation of the eyes or eyelids;
  • Excessive bleeding tendency;
  • No vision in the eye not included in the study;
  • Pregnant or breastfeeding;
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859702


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Abayomi Ogundele, PharmD Alcon Research
Principal Investigator: Mauro Silveira de Queiroz Campos, MD Federal University of São Paulo, Ophthalmology Service

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01859702     History of Changes
Other Study ID Numbers: RDG-11-235
First Posted: May 22, 2013    Key Record Dates
Results First Posted: August 7, 2013
Last Update Posted: August 7, 2013
Last Verified: June 2013
Keywords provided by Alcon Research:
Aqueous Humor
Moxifloxacin
Vigadexa
Additional relevant MeSH terms:
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Lens Diseases
Norgestimate, ethinyl estradiol drug combination
Cataract
Eye Diseases
Anti-Bacterial Agents
Moxifloxacin
Dexamethasone
Dexamethasone acetate
Ophthalmic Solutions
BB 1101
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral