Trial · NCT01808547
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
NCT01808547, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2016-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects. Trials, record NCT01808547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01808547
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
- NCT number
- NCT01808547
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 268 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Ocular Inflammation
- Interventions
- ISV-303, DuraSite Vehicle
- First posted
- 2013-03-11
- Last updated
- 2021-11-19
- Results first posted
- 2016-07-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Inflammation | 15 days | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Inflammation | 15 days | Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Inflammation | ISV-303 | 64 | participants | ||
| Ocular Inflammation | Vehicle | 19 | participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ISV-303 | 174 | |
| Overall Study | STARTED | Vehicle | 94 | |
| Overall Study | Safety Population | ISV-303 | 170 | |
| Overall Study | Safety Population | Vehicle | 85 | |
| Overall Study | mITT Population | ISV-303 | 168 | |
| Overall Study | mITT Population | Vehicle | 85 | |
| Overall Study | COMPLETED | ISV-303 | 137 | |
| Overall Study | COMPLETED | Vehicle | 48 | |
| Overall Study | NOT COMPLETED | ISV-303 | 37 | |
| Overall Study | NOT COMPLETED | Vehicle | 46 |
Source ClinicalTrials.gov
Adverse events6
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 | Ocular hypertension | Eye disorders | ISV-303 | 17 | 170 | |
| other | Ocular hypertension | Eye disorders | Vehicle | 5 | 85 | |
| serious | Colitis | Gastrointestinal disorders | ISV-303 | 0 | 170 | |
| serious | Colitis | Gastrointestinal disorders | Vehicle | 1 | 85 | |
| serious | Chest pain | General disorders | ISV-303 | 1 | 170 | |
| serious | Chest pain | General disorders | Vehicle | 0 | 85 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ISV-303 | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | ISV-303 | 17 | 170 |
| Total, other adverse events | Vehicle | 5 | 85 |
| Total, serious adverse events | ISV-303 | 1 | 170 |
| Total, serious adverse events | Vehicle | 1 | 85 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ISV-303 vs Vehicle: Ocular Inflammation | Trial comparisons |
| ISV-303 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/NCT01808547
GET https://conductscience.org/api/trials/v1/NCT01808547/registered