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CompletedNCT00575380Updated Sep 22, 2011Results posted

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

A Phase 4 interventional study of AzaSite Eye Drops and Vigamox Eye Drops in Bacterial Infections, Eye Infections and Cataract Extraction, sponsored by Merck Sharp & Dohme LLC. Completed at 13 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-22.

Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Bacterial Infections
  • Eye Infections
  • Cataract Extraction
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 116 is close to the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    AzaSite Eye Drops

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

    Drug: AzaSite Eye Drops

  • Active comparator
    Vigamox Eye Drops

    One drop three times a day for seven days

    Drug: Vigamox Eye Drops

Interventions

  • DrugAzaSite Eye Drops

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

    Also known as: AzaSite (azithromycin ophthalmic solution)

  • DrugVigamox Eye Drops

    One drop three times a day for seven days

    Also known as: Vigamox(moxifloxacin hydrochloride ophthalmic solution)

06

What researchers measure

Primary outcomes

  1. 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

    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 outcomes

  1. 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

07

Results

Posted Sep 16, 2009

Participant flow

Participant flow — Overall Study
MilestoneAzasiteVigamox
Started5858
Completed5755
Not completed13
Withdrew: Withdrawal by subject10
Withdrew: Adverse event01
Withdrew: Various02

Outcome measures

PrimaryConjunctiva 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

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
Reported as:
Mean · ug/g
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
ug/gAzasiteVigamox
Timepoint 1 - 1 hr (AzaSite and Vigamox)40.4 ± 19.77525.747 ± 3.4775
Timepoint 2 - 12 hrs (AzaSite)/8 hrs (Vigamox)33.55 ± 11.811.051 ± .8099
Timepoint 3 - 48 hrs (AzaSite and Vigamox)559.733 ± 1011.6581.129 ± 1.1673
Timepoint 4 - 49 hrs (AzaSite and Vigamox)98.6 ± 4.53515.754 ± 15.4107
Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox)287.75 ± 433.4355.862 ± .6801
Timepoint 6 - 144 hrs (AzaSite and Vigamox)175.017 ± 88.9250.305 ± .0917
Timepoint 7 - 145 hrs (AzaSite and Vigamox)269.46 ± 316.28215.432 ± 4.0756
Timepoint 8 - 168 hrs (AzaSite and Vigamox)261.125 ± 169.1224.322 ± .1792
Timepoint 9 - 216 hrs (AzaSite and Vigamox)273.9 ± 160.4984.165 ± .1974
Timepoint 10 - 312 (AzaSite and Vigamox)63.867 ± 51.1578.011 ± .0098
SecondaryAqueous 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
Reported as:
Mean · ug/mL
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
ug/mLAzasiteVigamox
Timepoint 1- 1 hr (AzaSite and Vigamox).022 ± .0297.582 ± .506
Timepoint 2- 12 hrs (AzaSite)/ 8 hrs (Vigamox).088 ± .0084.113 ± .0729
Timepoint 3 - 48 hrs (AzaSite and Vigamox).047 ± .0515.079 ± .0543
Timepoint 4 - 49 hrs (AzaSite and Vigamox).023 ± .0183.765 ± .5657
Timepoint 5 - 72 hrs (AzaSite)/ 56 hr (Vigamox).02 ± .0099.084 ± .0261
Timepoint 6 - 144 hrs (AzaSite and Vigamox).026 ± .0175.225 ± .1456
Timepoint 7 - 145 hrs (AzaSite and Vigamox).052 ± .0694.669 ± .402
Timepoint 8 - 168 hrs (AzaSite and Vigamox).035 ± .0276.059 ± .0265
Timepoint 9 - 216 hrs (AzaSite and Vigamox).028 ± .0353.071 ± .0845
Timepoint 10 - 312 hrs (AzaSite and Vigamox).011 ± .0102.017 ± .0189

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Azasite—0/58 (0%)3/58 (5.2%)
Vigamox—0/58 (0%)2/58 (3.4%)
Most frequent other events
Most frequent other events
EventAzasiteVigamox
Intraocular pressure increasedInvestigations3/582/58

Baseline characteristics

Age Continuous
Age Continuous(years)AzasiteVigamoxTotal
Mean71.0 ± 7.5766.3 ± 10.0268.6 ± 9.15
Sex: Female, Male
Sex: Female, Male(Participants)AzasiteVigamoxTotal
Female342862
Male243054
08

Study locations

13 sites
  • Cornea Consultants of Arizone
    Phoenix, Arizona 85032, United States
  • Eye Care Arkansas
    Little Rock, Arkansas 72205, United States
  • North Valley Eye Medical Group
    Mission Hills, California 91345, United States
  • Center for Excellence in Eye Care
    Miami, Florida 33176, United States
  • Eye Center of North Florida
    Panama City, Florida 32405, United States
  • Coastal Research Associates, LLC
    Atlanta, Georgia 30339, United States
  • Kentuckiana Institute for Eye Research
    Louisville, Kentucky 40207, United States
  • Ophthalmology Associates
    St. Louis, Missouri 63131, United States
  • Ophthalmic Consultants of Long Island
    Rockville Centre, New York 11563, United States
  • Eye Care Specialists
    Kingston, Pennsylvania 18704, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29464, United States
  • Glaucoma Consultants and Center for Eye Research
    Mount Pleasant, South Carolina 29464, United States
  • Corona Research Consultants
    El Paso, Texas 79904, United States
09

References and documents

Publications

  • 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. PubMed 20813346 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00575380
Lead sponsor
Merck Sharp & Dohme LLC
First posted
Dec 18, 2007
Start date
Dec 2007
Primary completion
Jun 2008
Results posted
Sep 16, 2009
Last update
Sep 22, 2011

Study contacts

Reza Haque, MD
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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