Trial · NCT00429923
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)
NCT00429923, Phase 3, Completed, Sirion Therapeutics, Inc.; results first posted 2009-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a). Trials, record NCT00429923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429923
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)
- NCT number
- NCT00429923
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 219 participants, actual
- Lead sponsor
- Sirion Therapeutics, Inc.
- Conditions
- Inflammation
- Interventions
- Difluprednate, Difluprednate, Placebo
- First posted
- 2007-02-01
- Last updated
- 2009-07-02
- Results first posted
- 2009-07-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). | Day 8 (QID) | Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells. |
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 | Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo). | Day 8 (QID) | The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo). | Difluprednate 0.05% BID | Proportion of subjects w/AC cell grade=0 on Day 8 | 0 | participants | |
| Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo). | Difluprednate 0.05% QID | Proportion of subjects w/AC cell grade=0 on Day 8 | 19 | participants | |
| Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo). | Placebo | Proportion of subjects w/AC cell grade=0 on Day 8 | 13 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Difluprednate 0.05% BID | 57 | |
| Overall Study | STARTED | Difluprednate 0.05% QID | 55 | |
| Overall Study | STARTED | Placebo | 107 | |
| Overall Study | COMPLETED | Difluprednate 0.05% BID | 52 | |
| Overall Study | COMPLETED | Difluprednate 0.05% QID | 51 | |
| Overall Study | COMPLETED | Placebo | 68 | |
| Overall Study | NOT COMPLETED | Difluprednate 0.05% BID | 5 | |
| Overall Study | NOT COMPLETED | Difluprednate 0.05% QID | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 39 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19101421 | DERIVED |
Source PubMed
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
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/NCT00429923
GET https://conductscience.org/api/trials/v1/NCT00429923/registered