Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
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| ClinicalTrials.gov Identifier: NCT00105469 |
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Recruitment Status :
Completed
First Posted : March 15, 2005
Results First Posted : October 27, 2011
Last Update Posted : December 16, 2013
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by:
Merck Sharp & Dohme LLC
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bacterial Conjunctivitis | Drug: AzaSite Drug: Tobramycin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 743 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pink Eye
| Arm | Intervention/treatment |
|---|---|
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Experimental: AzaSite
1.0% azithromycin in DuraSite
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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. |
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Active Comparator: Tobramycin
0.3% tobramycin
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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. |
Primary Outcome Measures :
- Number of Participants Who Achieved Clinical Resolution at Visit 3 [ Time Frame: Visit 3 (Day 6) ]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) ]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).
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| Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105469
Locations
Show 26 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
| Other Study ID Numbers: |
P08633 C-01-401-004 |
| First Posted: | March 15, 2005 Key Record Dates |
| Results First Posted: | October 27, 2011 |
| Last Update Posted: | December 16, 2013 |
| Last Verified: | November 2013 |
Keywords provided by Merck Sharp & Dohme LLC:
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Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection |
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial Conjunctivitis Conjunctival Diseases Eye Diseases Eye Infections, Bacterial Bacterial Infections |
Bacterial Infections and Mycoses Infections Eye Infections Tobramycin Anti-Bacterial Agents Anti-Infective Agents |