NCT00564447

Brief Summary

The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 26, 2011

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

Same day

First QC Date

November 20, 2007

Results QC Date

June 27, 2011

Last Update Submit

September 20, 2011

Conditions

Bacterial InfectionsEye Infections

Outcome Measures

Primary Outcomes (2)

  • Assessment of Pharmacokinetic Parameters

    Up to 24 hours

  • Assessment of Pharmacokinetic Parameters

    Conjunctiva Concentration of Azithromycin and Moxifloxacin

    Over 24 hours

Study Arms (8)

Azithromycin-30 minutes Post dose

EXPERIMENTAL
Drug: Azithromycin

Azithromycin-2 hours post dose

EXPERIMENTAL
Drug: Azithromycin

Azithromycin-12 hours post dose

EXPERIMENTAL
Drug: Azithromycin

Azithromycin-24 hours post dose

EXPERIMENTAL
Drug: Azithromycin

Moxifloxacin-30 minutes post dose

EXPERIMENTAL
Drug: Moxifloxacin

Moxifloxacin-2 hours post dose

EXPERIMENTAL
Drug: Moxifloxacin

Moxifloxacin-12 hours post dose

EXPERIMENTAL
Drug: Moxifloxacin

Moxafloxacin-24 hours post dose

EXPERIMENTAL
Drug: Moxifloxacin

Interventions

AzithromycinDRUG

azithromycin topical solution 1% given as a single drop in a single eye

Also known as: AzaSite
Azithromycin-12 hours post doseAzithromycin-2 hours post doseAzithromycin-24 hours post doseAzithromycin-30 minutes Post dose
MoxifloxacinDRUG

Moxifloxacin topical solution given as a single drop in a single eye

Also known as: Vigamox
Moxafloxacin-24 hours post doseMoxifloxacin-12 hours post doseMoxifloxacin-2 hours post doseMoxifloxacin-30 minutes post dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

You may not qualify if:

  • Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
  • Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
  • Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
  • Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
  • Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.

    PMID: 19108788DERIVED

MeSH Terms

Conditions

Bacterial InfectionsEye Infections

Interventions

AzithromycinMoxifloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Director of Clinical Research
Organization
Inspire Pharmaceuticals, Inc.
kkuhn@inspirepharm.com
010-941-9777

Study Officials

  • Reza Haque

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 28, 2007

Study Start

December 1, 2007

Primary Completion

December 1, 2007

Last Updated

September 22, 2011

Results First Posted

July 26, 2011

Record last verified: 2011-09