Trial · NCT03004924
Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
NCT03004924, Phase 3, Completed, Shire; results first posted 2019-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo. Trials, record NCT03004924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03004924
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
- NCT number
- NCT03004924
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 753 participants, actual
- Lead sponsor
- Shire
- Conditions
- Bacterial Conjunctivitis
- Interventions
- SHP640, PVP-I 0.6%, Placebo
- First posted
- 2016-12-29
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2016-003361-25
- Results first posted
- 2019-10-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | Day 5 | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. |
| Secondary | Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | Baseline, Day 5 | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. |
| Secondary | Number of Participants With Clinical Resolution | Day 3, 8 and 12 | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. |
| Secondary | Number of Participants With Bacterial Eradication | Day 3, 8 and 12 | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. |
| Secondary | Bulbar Conjunctival Injection Score | Day 3, 5, 8 and 12 | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. |
| Secondary | Change From Baseline in the Bulbar Conjunctival Injection Score | Baseline, Day 3, 5, 8 and 12 | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. |
| Secondary | Ocular Conjunctival Discharge Score | Day 3, 5, 8 and 12 | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. |
| Secondary | Change From Baseline in the Ocular Conjunctival Discharge Score | Baseline, Day 3, 5, 8 and 12 | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. |
| Secondary | Global Clinical Score | Day 3, 5, 8 and 12 | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. |
| Secondary | Change From Baseline in the Global Clinical Score | Baseline, Day 3, 5, 8 and 12 | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | SHP640 | 111 | Participants | ||
| Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | PVP-I 0.6% | 0 | Participants | ||
| Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | Placebo | 95 | Participants | ||
| Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | SHP640 | 94 | Participants | ||
| Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | PVP-I 0.6% | 0 | Participants | ||
| Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | Placebo | 102 | Participants | ||
| Number of Participants With Clinical Resolution | SHP640 | Day 3 | 39 | Participants | |
| Number of Participants With Clinical Resolution | PVP-I 0.6% | Day 3 | 6 | Participants | |
| Number of Participants With Clinical Resolution | Placebo | Day 3 | 39 | Participants | |
| Number of Participants With Clinical Resolution | SHP640 | Day 8 | 148 | Participants |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP640 | 324 | |
| Overall Study | STARTED | PVP-I 0.6% | 108 | |
| Overall Study | STARTED | Placebo | 321 | |
| Overall Study | COMPLETED | SHP640 | 297 | |
| Overall Study | COMPLETED | PVP-I 0.6% | 94 | |
| Overall Study | COMPLETED | Placebo | 293 | |
| Overall Study | NOT COMPLETED | SHP640 | 27 | |
| Overall Study | NOT COMPLETED | PVP-I 0.6% | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 28 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Instillation site pain | General disorders | SHP640 | 67 | 323 | 68 |
| other | Instillation site pain | General disorders | PVP-I 0.6% | 26 | 108 | 26 |
| other | Instillation site pain | General disorders | Placebo | 7 | 321 | 7 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP640 | 0 | 323 |
| Total, all-cause mortality | PVP-I 0.6% | 0 | 108 |
| Total, all-cause mortality | Placebo | 0 | 321 |
| Total, other adverse events | SHP640 | 67 | 323 |
| Total, other adverse events | PVP-I 0.6% | 26 | 108 |
| Total, other adverse events | Placebo | 7 | 321 |
| Total, serious adverse events | SHP640 | 0 | 323 |
| Total, serious adverse events | PVP-I 0.6% | 0 | 108 |
| Total, serious adverse events | Placebo | 0 | 321 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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