A Phase 3 interventional study of AzaSite and Tobramycin in Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme LLC. Completed at 26 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2013-12-16.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 743 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
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Exclusion Criteria:
1.0% azithromycin in DuraSite
Drug: AzaSite
0.3% tobramycin
Drug: Tobramycin
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 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.
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).
Time frame: Visit 3 (Day 6)
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).
Time frame: Visit 3 (Day 6)
| Milestone | AzaSite | Tobramycin |
|---|---|---|
| Started | 365 | 378 |
| Completed | 343 | 367 |
| Not completed | 22 | 11 |
| Withdrew: Adverse event | 9 | 8 |
| Withdrew: Protocol violation | 4 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Other reason | 4 | 0 |
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
| Participants | AzaSite | Tobramycin |
|---|---|---|
| Number of Participants Who Achieved Clinical Resolution at Visit 3 | 127 | 123 |
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).
| Participants | AzaSite | Tobramycin |
|---|---|---|
| Number of Participants Who Achieved Bacterial Eradication at Visit 3 | 140 | 148 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AzaSite | — | 0/365 (0%) | 0/365 (0%) |
| Tobramycin | — | 0/378 (0%) | 0/378 (0%) |
| Age, Continuous(years) | AzaSite | Tobramycin | Total |
|---|---|---|---|
| Mean | 17.9 ± 20.23 | 22.8 ± 22.61 | 20.4 ± 21.55 |
| Sex: Female, Male(Participants) | AzaSite | Tobramycin | Total |
|---|---|---|---|
| Female | 81 | 90 | 171 |
| Male | 78 | 67 | 145 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin