Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00105469
First received: March 14, 2005
Last updated: November 21, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Conjunctivitis |
Drug: AzaSite Drug: Tobramycin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis |
Resource links provided by NLM:
Drug Information available for:
Tobramycin
Tobramycin sulfate
Azithromycin dihydrate
Azithromycin monohydrate
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Participants Who Achieved Clinical Resolution at Visit 3 [ Time Frame: Visit 3 (Day 6) ] [ Designated as safety issue: No ]Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Secondary Outcome Measures:
- Number of Participants Who Achieved Bacterial Eradication at Visit 3 [ Time Frame: Visit 3 (Day 6) ] [ Designated as safety issue: No ]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).
| Enrollment: | 743 |
| Study Start Date: | July 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AzaSite
1.0% azithromycin in DuraSite
|
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.
|
|
Active Comparator: Tobramycin
0.3% tobramycin
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 1 Year and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105469
Show 26 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105469
Show 26 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00105469 History of Changes |
| Other Study ID Numbers: | P08633 C-01-401-004 |
| Study First Received: | March 14, 2005 |
| Results First Received: | August 1, 2011 |
| Last Updated: | November 21, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Bacterial Conjunctival Diseases Eye Diseases Eye Infections, Bacterial Bacterial Infections Eye Infections |
Infection Ophthalmic Solutions Tobramycin Azithromycin Pharmaceutical Solutions Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 27, 2016