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Comparison · NCT00105534-ddcbe57b

AzaSite vs Vehicle: Participants Who Achieved Clinical Resolution

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. AzaSite vs Vehicle: Participants Who Achieved Clinical Resolution. Trial comparisons, record NCT00105534-ddcbe57b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00105534-ddcbe57b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6310.5450.709wilson
Risk in group 20.4970.4170.576wilson
Risk difference, group 1 minus group 20.1340.01740.245newcombe hybrid score
Risk ratio, group 1 over group 21.271.031.56log
Odds ratio, group 1 over group 21.731.072.8log
Number needed to treat, for one more participant with the outcome on AzaSite than on Vehicle7.464.0857.5from the risk difference interval

Groups2

Group 2 names the comparator: vehicle.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1AzaSite82130OG000
Group 2Vehicle74149OG001

Outcome

Type
PRIMARY
Title
Participants Who Achieved Clinical Resolution
Description
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)
Population
Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.

Source ClinicalTrials.gov

Trial

Title
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
NCT number
NCT00105534
Phases
PHASE3
Conditions
Bacterial Conjunctivitis
Interventions
AzaSite, Vehicle
Lead sponsor
Merck Sharp & Dohme LLC
Results first posted
2011-10-27

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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