Trial · NCT03004924
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | Day 5 | Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | Baseline, Day 5 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Resolution | Day 3, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bacterial Eradication | Day 3, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Bulbar Conjunctival Injection Score | Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Bulbar Conjunctival Injection Score | Baseline, Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Ocular Conjunctival Discharge Score | Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Ocular Conjunctival Discharge Score | Baseline, Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Global Clinical Score | Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Global Clinical Score | Baseline, Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Modified Clinical Resolution | Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Expanded Clinical Resolution | Day 3, 5, 8 and 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Resolution | Baseline to Day 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. | Days | MEDIAN |
| SECONDARY | Number of Participants Who Used Rescue Medication | Baseline to Day 12 | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study drug administration up to 14 days | Safety population included all participants who received at least one dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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