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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105534
Other study ID # P08635
Secondary ID C-01-401-003
Status Completed
Phase Phase 3
First received March 15, 2005
Last updated October 29, 2013
Start date July 2004
Est. completion date January 2006

Study information

Verified date October 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 vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.


Recruitment information / eligibility

Status Completed
Enrollment 685
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 12 Months 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, 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 the 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), Primary Purpose: Treatment


Intervention

Drug:
AzaSite
1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Other:
Vehicle
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Locations

Country Name City State
United States Metaclin Research, Inc. Austin Texas
United States Bend Memorial Clinic Bend Oregon
United States Bossier Optical Inc. Bossier City Louisiana
United States Charlotte Eye, Ear, Nose, and Throat Charlotte North Carolina
United States Horizon Eye Center Charlotte North Carolina
United States Abrams Eye Center Cleveland Ohio
United States Rx For Life, Inc. Cudahy California
United States Welborn Clinic and Welborn Clinic East Evansville Indiana
United States I Care! Eye Care! Flagstaff Arizona
United States Groat Eyecare Associates Greensboro North Carolina
United States Marc Sanders, MD Houston Texas
United States Physicians Eye Associates & Cosmetic Laser Houston Texas
United States Precision Eye Care Huntington New York
United States Bohn and Joseph Eye Center Lafayette Louisiana
United States Mountain View Eye Center Layton Utah
United States Taustine Eye Center Louisville Kentucky
United States University Eye Surgeons Maryville Tennessee
United States Total Eye Care, PA Memphis Tennessee
United States Advanced Healthcare, SC Milwaukee Wisconsin
United States Eye Associates Nashville Tennessee
United States Mississippi Eye Associates Ocean Springs Mississippi
United States Mark Mayo, MD Pasadena Texas
United States North Bay Eye Associates Petaluma and Santa Rosa California
United States Clinical Research Laboratories Piscataway New Jersey
United States Advanced Eyecare and Laser Center Runnemede New Jersey
United States Cottonwood Eye and Laser Clinic Salt Lake City Utah
United States Sun Research Institute San Antonio Texas
United States San Diego Eye and Laser Center San Diego California
United States International Eye Center Tampa Florida
United States Opticare Eye Health Center Waterbury Connecticut
United States Western States Clinical Research Wheat Ridge Colorado
United States The Louisiana Eye Center Zachary Louisiana

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 Participants Who Achieved Clinical Resolution Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. Visit 3 (Days 6-7) No
Secondary Participants Who Achieved Bacteriological Eradication Bacterial eradication is defined as the 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 6-7) No
See also
  Status Clinical Trial Phase
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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 NCT00105469 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) 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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