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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105469
Other study ID # P08633
Secondary ID C-01-401-004
Status Completed
Phase Phase 3
First received March 14, 2005
Last updated November 21, 2013
Start date July 2004
Est. completion date October 2005

Study information

Verified date November 2013
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 clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.


Recruitment information / eligibility

Status Completed
Enrollment 743
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility Inclusion Criteria:

- Male or female subject, of any race, who is at least 1 year of age.

- Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.

- The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.

- Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

- Any uncontrolled systemic disease or debilitating disease.

- Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.

- Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.

- Any active upper respiratory tract infection.

- Pregnant or nursing females.

- Use of any antibiotic (topical or systemic) within 72 hours of enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
AzaSite
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
Tobramycin
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

Locations

Country Name City State
United States Palm Beach Eye Associates Atlantis Florida
United States Renaissance Center Birmingham Alabama
United States Jon Fishburn, MD Boise Idaho
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States The Eye Associates Bradenton Florida
United States Mason Eye Institute Columbia Missouri
United States Ophthalmology Associates Creve Coeur Missouri
United States Corona Research Consultants, Inc. El Paso Texas
United States Medisphere Medical Research Center, LLC Evansville Indiana
United States Southern Eye Associates, PA Greenville South Carolina
United States Cornerstone Eye Care High Point North Carolina
United States Huntington Medical Group Huntington Station New York
United States Hutchinson Clinic Hutchinson Kansas
United States Alan Shuster, MD Jupiter Florida
United States Research Eye Care Center Kansas City Missouri
United States Children's Eye Physicians Littleton Colorado
United States Cottonwood Ophthalmology Associates Murray Utah
United States Pasco Eye Institute New Port Richey Florida
United States Tukoi Institute for Clinical Research North Miami Beach Florida
United States Advanced Eye Care Panama City Florida
United States Irving Weinberger, MD Pittsburgh Pennsylvania
United States Eye Health Northwest Portland Oregon
United States Ophthalmology Associates Princeton New Jersey
United States Rockwood Clinic, PS-Eye Center Spokane Washington
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Presidential Eye Center West Palm Beach Florida

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 Number of Participants Who Achieved Clinical Resolution at Visit 3 Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection). Visit 3 (Day 6) No
Secondary Number of Participants Who Achieved Bacterial Eradication at Visit 3 Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s). Visit 3 (Day 6) No
See also
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Completed NCT00972777 - Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis Phase 2/Phase 3
Completed NCT00759148 - Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT00798577 - Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment Phase 4
Completed NCT00331916 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT02432807 - Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis Phase 3
Completed NCT01573910 - An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients Phase 3
Terminated NCT01330355 - Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis Phase 3
Completed NCT00332293 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT03004924 - Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo Phase 3
Completed NCT02980523 - Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) Phase 2
Completed NCT01877694 - Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis Phase 2
Completed NCT01175590 - Safety of Besivanceā„¢ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Phase 3
Completed NCT00464438 - A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis Phase 4
Completed NCT00312338 - Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Phase 4
Recruiting NCT03235141 - Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers Phase 1
Completed NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) Phase 3
Recruiting NCT06363292 - Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. Phase 1
Withdrawn NCT01238783 - Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis Phase 2
Terminated NCT01740388 - Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Phase 3

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