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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575380
• Other study ID #: 041-103
• Secondary ID: P08655
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: September 20, 2011
• Start date: December 2007

Study information

• Verified date: September 2011
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bacterial Infections
• Cataract
• Cataract Extraction
• Eye Infections
• Infection

Intervention

Drug:
• AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days.
• Vigamox Eye Drops
One drop three times a day for seven days

Locations

Country	Name	City	State
United States	Coastal Research Associates, LLC	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Corona Research Consultants	El Paso	Texas
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Eye Care Arkansas	Little Rock	Arkansas
United States	Kentuckiana Institute for Eye Research	Louisville	Kentucky
United States	Center for Excellence in Eye Care	Miami	Florida
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Glaucoma Consultants and Center for Eye Research	Mount Pleasant	South Carolina
United States	Eye Center of North Florida	Panama City	Florida
United States	Cornea Consultants of Arizone	Phoenix	Arizona
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Ophthalmology Associates	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312	No
Secondary	Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)		Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312	No