Trials / Completed
CompletedNCT01124045
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred Forte™) QID for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Detailed description
Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Difluprednate ophthalmic emulsion, 0.05% | Topical ocular administration |
| DRUG | Prednisolone acetate ophthalmic suspension, 1.0% | Topical ocular administration |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2010-05-14
- Last updated
- 2013-06-19
- Results posted
- 2013-06-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01124045. Inclusion in this directory is not an endorsement.