Trial · NCT00347932
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
NCT00347932, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2009-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. Trials, record NCT00347932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00347932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
- NCT number
- NCT00347932
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 957 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Acute Bacterial Conjunctivitis
- Interventions
- ISV-403, Vehicle
- First posted
- 2006-07-04
- Last updated
- 2015-03-24
- Results first posted
- 2009-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 5 +/- 1 day | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection |
| Primary | Microbial Eradication of Baseline Bacterial Infection | Day 5 +/- 1 day | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. |
| Secondary | Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 8 or 9 | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection |
| Secondary | Microbial Eradication of Baseline Bacterial Infection | Day 8 or 9 | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 5 +/- 1 day | Modified intent to treat population, culture confirmed, as randomized | Participants | NUMBER |
| PRIMARY | Microbial Eradication of Baseline Bacterial Infection | Day 5 +/- 1 day | Modified Intent to treat population, culture confirmed, as randomized. | Participants | NUMBER |
| SECONDARY | Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 8 or 9 | Modified intent to treat population, culture confirmed, as randomized | Participants | NUMBER |
| SECONDARY | Microbial Eradication of Baseline Bacterial Infection | Day 8 or 9 | Modified intent to treat population, culture confirmed, as randomized. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | ISV-403 | 90 | Participants | ||
| Clinical Resolution of Baseline Bacterial Conjunctivitis | Vehicle | 63 | Participants | ||
| Microbial Eradication of Baseline Bacterial Infection | ISV-403 | 182 | Participants | ||
| Microbial Eradication of Baseline Bacterial Infection | Vehicle | 114 | Participants | ||
| Clinical Resolution of Baseline Bacterial Conjunctivitis | ISV-403 | 168 | Participants | ||
| Clinical Resolution of Baseline Bacterial Conjunctivitis | Vehicle | 132 | Participants | ||
| Microbial Eradication of Baseline Bacterial Infection | ISV-403 | 176 | Participants | ||
| Microbial Eradication of Baseline Bacterial Infection | Vehicle | 137 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ISV-403 | 475 | |
| Overall Study | STARTED | Vehicle | 482 | |
| Overall Study | COMPLETED | ISV-403 | 444 | |
| Overall Study | COMPLETED | Vehicle | 430 | |
| Overall Study | NOT COMPLETED | ISV-403 | 31 | |
| Overall Study | NOT COMPLETED | Vehicle | 52 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | ISV-403 | 1 | 442 | 1 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Vehicle | 1 | 432 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ISV-403 | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | ISV-403 | 0 | 741 |
| Total, other adverse events | Vehicle | 0 | 760 |
| Total, serious adverse events | ISV-403 | 1 | 442 |
| Total, serious adverse events | Vehicle | 1 | 432 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ISV-403 vs Vehicle: Clinical Resolution of Baseline Bacterial Conjunctivitis | Trial comparisons |
| ISV-403 vs Vehicle: Microbial Eradication of Baseline Bacterial Infection | Trial comparisons |
| ISV-403 vs Vehicle: Clinical Resolution of Baseline Bacterial Conjunctivitis | Trial comparisons |
| ISV-403 vs Vehicle: Microbial Eradication of Baseline Bacterial Infection | Trial comparisons |
| ISV-403 vs Vehicle: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00347932
GET https://conductscience.org/api/trials/v1/NCT00347932/registered