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OpenTrials
Completed

NCT Number: NCT01859702

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Drug

Other names: Vigadexa®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 22, 2013
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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