Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

NCT00575367 | Completed Phase 4 Results

• 2 other identifiers: 041-101P08653
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Conditions

Bacterial Infections; Eye Infections

Outcome Measures

Primary Outcomes (1)

• Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.

  15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours

Study Arms (2)

AzaSite

ACTIVE COMPARATOR

Drug: AzaSite (azithromycin ophthalmic solution)

Vigamox

ACTIVE COMPARATOR

Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

Interventions

AzaSite (azithromycin ophthalmic solution) DRUG

One drop ophthalmic solution at Visit 2

AzaSite

Vigamox (moxifloxacin hydrochloride ophthalmic solution) DRUG

One drop ophthalmic solution at Visit 2

Vigamox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
• Have normal lid anatomy.

You may not qualify if:

• Have an abnormal biomicroscopy or ophthalmoscopy exam.
• Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
• Have used artificial tears in the past thirty days.
• Have a diagnosis of on-going ocular infection or lid margin inflammation.
• Have ever had penetrating ocular surface or intraocular surgery.
• 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.
• Have had corneal or lid abnormalities.
• Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
• Have any ocular pathology with the exception of cataracts.
• Have a serious systemic disease or uncontrolled medical condition.
• Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
• Have a history of liver or kidney disease resulting in persisting dysfunction.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Bacterial Infections; Eye Infections

Interventions

Azithromycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Karen Kuhn/ Director
• Organization: Inspire Pharmaceuticals, Inc.

kkuhn@inspirepharm.com

919 941-9777

Study Officials

• Reza Haque, MD

  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: December 14, 2007
• First Posted: December 18, 2007
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: September 22, 2011
• Results First Posted: September 17, 2009

Record last verified: 2011-09

Locations

US (1)