---
title: Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)
nct_id: NCT00616993
overall_status: COMPLETED
phase: PHASE3
sponsor: Sirion Therapeutics, Inc.
study_type: INTERVENTIONAL
primary_condition: Inflammation
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00616993.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00616993"
ct_last_update_post_date: 2011-07-01
last_seen_at: "2026-05-12T07:26:21.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

**NCT ID:** [NCT00616993](https://clinicaltrials.gov/study/NCT00616993)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Sirion Therapeutics, Inc.
- **Conditions:** Inflammation
- **Start Date:** 2008-01
- **Completion Date:** 2008-03
- **CT.gov Last Update:** 2011-07-01

## Brief Summary

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.

## Eligibility

- **Minimum age:** 2 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Scheduled for unilateral ocular surgery.

Exclusion Criteria:

* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
```

## Arms

- **2** (PLACEBO_COMPARATOR) — Vehicle
- **1** (EXPERIMENTAL) — Difluprednate

## Interventions

- **Difluprednate** (DRUG) — Difluprednate
- **Placebo** (OTHER) — Vehicle

## Primary Outcomes

- **The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.** _(time frame: Day 14)_

## Secondary Outcomes

- **The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.** _(time frame: Day 7)_

## Locations (1)

- Eye Associates of Fort Myers, Fort Myers, Florida, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `locations.eye associates of fort myers|fort myers|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00616993.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00616993*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*