Back to resultsPharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Sponsored by
About this trial
This is an interventional basic science trial for Cataract focused on measuring Aqueous Humor, Moxifloxacin, Vigadexa
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VIGADEXA
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean Aqueous Humor Concentration of Moxifloxacin
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01859702
Brief Title
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Official Title
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Aqueous Humor, Moxifloxacin, Vigadexa
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIGADEXA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Other Intervention Name(s)
Vigadexa®
Primary Outcome Measure Information:
Title
Mean Aqueous Humor Concentration of Moxifloxacin
Description
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.
Time Frame
Day 3 (operative day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abayomi Ogundele, PharmD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mauro Silveira de Queiroz Campos, MD
Organizational Affiliation
Federal University of São Paulo, Ophthalmology Service
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
We'll reach out to this number within 24 hrs