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Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

Primary Purpose

Bacterial Infections, Eye Infections, Cataract Extraction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AzaSite Eye Drops
Vigamox Eye Drops
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bacterial Infections

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
  • Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.

Exclusion Criteria:

  • Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Have a history of ocular pemphigoid.
  • Have ever had penetrating ocular surface surgery.
  • Have had intraocular surgery within the past 3 months.
  • Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
  • Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
  • Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
  • Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
  • Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
  • Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
  • Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
  • Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
  • Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
  • Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
  • Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.

Sites / Locations

  • Cornea Consultants of Arizone
  • Eye Care Arkansas
  • North Valley Eye Medical Group
  • Center for Excellence in Eye Care
  • Eye Center of North Florida
  • Coastal Research Associates, LLC
  • Kentuckiana Institute for Eye Research
  • Ophthalmology Associates
  • Ophthalmic Consultants of Long Island
  • Eye Care Specialists
  • Medical University of South Carolina
  • Glaucoma Consultants and Center for Eye Research
  • Corona Research Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AzaSite Eye Drops

Vigamox Eye Drops

Arm Description

One drop two times a day for two days and once a day for the next five days

One drop three times a day for seven days

Outcomes

Primary Outcome Measures

Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Nominal time is scheduled time relative to administration of the first eye drop

Secondary Outcome Measures

Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)

Full Information

First Posted
December 12, 2007
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00575380
Brief Title
Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Official Title
A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Eye Infections, Cataract Extraction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AzaSite Eye Drops
Arm Type
Active Comparator
Arm Description
One drop two times a day for two days and once a day for the next five days
Arm Title
Vigamox Eye Drops
Arm Type
Active Comparator
Arm Description
One drop three times a day for seven days
Intervention Type
Drug
Intervention Name(s)
AzaSite Eye Drops
Other Intervention Name(s)
AzaSite (azithromycin ophthalmic solution)
Intervention Description
One drop two times a day for two days and once a day for the next five days.
Intervention Type
Drug
Intervention Name(s)
Vigamox Eye Drops
Other Intervention Name(s)
Vigamox(moxifloxacin hydrochloride ophthalmic solution)
Intervention Description
One drop three times a day for seven days
Primary Outcome Measure Information:
Title
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Description
Nominal time is scheduled time relative to administration of the first eye drop
Time Frame
Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Secondary Outcome Measure Information:
Title
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Time Frame
Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are scheduled to undergo routine cataract surgery by the investigator's preferred technique. Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye. Exclusion Criteria: Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Have a history of ocular pemphigoid. Have ever had penetrating ocular surface surgery. Have had intraocular surgery within the past 3 months. Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site. Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection. Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery). Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera. Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study. Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite. Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox. Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis. Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin. Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance. Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cornea Consultants of Arizone
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Eye Care Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Eye Center of North Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Kentuckiana Institute for Eye Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ophthalmology Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Corona Research Consultants
City
El Paso
State/Province
Texas
ZIP/Postal Code
79904
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20813346
Citation
Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.
Results Reference
derived

Learn more about this trial

Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

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