A Phase 3 interventional study of AzaSite and Vehicle in Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme LLC. Completed at 32 sites in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2013-11-21.
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 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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 685 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:
Drug: AzaSite
Other: Vehicle
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.
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.
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.
Time frame: Visit 3 (Days 6-7)
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).
Time frame: Visit 3 (Day 6-7)
| Milestone | AzaSite | Vehicle |
|---|---|---|
| Started | 335 | 350 |
| Completed | 313 | 317 |
| Not completed | 22 | 33 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Protocol violation | 1 | 4 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Lost to follow-up | 5 | 1 |
| Withdrew: Lack of efficacy | 7 | 15 |
| Withdrew: Treatment unmasked | 1 | 0 |
| Withdrew: Other reason | 0 | 2 |
Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
| Participants | AzaSite | Vehicle |
|---|---|---|
| Participants Who Achieved Clinical Resolution | 82 | 74 |
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).
| Participants | AzaSite | Vehicle |
|---|---|---|
| Participants Who Achieved Bacteriological Eradication | 115 | 99 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AzaSite | — | 0/333 (0%) | 0/333 (0%) |
| Vehicle | — | 2/350 (0.6%) | 0/350 (0%) |
| Event | AzaSite | Vehicle |
|---|---|---|
| Cornela UlcerEye disorders | 0/333 | 1/350 |
| Cerebrovascular AccidentNervous system disorders | 0/333 | 1/350 |
| Age Continuous(years) | AzaSite | Vehicle | Total |
|---|---|---|---|
| Mean | 25.6 ± 24.49 | 30.8 ± 28.07 | 28.4 ± 26.54 |
| Sex: Female, Male(Participants) | AzaSite | Vehicle | Total |
|---|---|---|---|
| Female | 82 | 78 | 160 |
| Male | 48 | 71 | 119 |
The record gives a start of Jul 2004, a primary completion of Jan 2006 and a completion of Jan 2006. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2011, 5 years 9 months after primary completion.
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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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