Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Condition: Bacterial Infections; Eye Infections; Cataract Extraction
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Eye Infections; Cataract
Intervention: AzaSite Eye Drops; Vigamox Eye Drops
Intervention 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
Intervention MeSH terms: Moxifloxacin; Azithromycin; Pharmaceutical Solutions; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

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.