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”

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

Study Type: Interventional

Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: AzaSite (azithromycin ophthalmic solution)
  • One drop three times a day for two days and once a day for the next five days
• Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
  • One drop three times a day for seven days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2

Primary Measures

• Assessment of pharmacokinetic parameters
  • Time Frame: Up to 14 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Inspire Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Reza Haque, MD Study Director Inspire Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00575380

Study ID Number: 041-103

ClinicalTrials.gov Identifier: NCT00575380

Health Authority: United States: Food and Drug Administration