Clinical trial NCT01124045: Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataracts
Inflammation
Keywords: Pediatric
Cataracts
Inflammation
Durezol
Pred Forte
Difluprednate
Prednisolone
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 80
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 0 to 3 years of age.
* Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
* Informed consent signed by a parent or legal guardian.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
* Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
* Patients with posttraumatic cataract.
* Active uveitis in the study eye.
* Ocular neoplasm in the study eye.
* Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
* Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
* Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
* History of steroid-induced intraocular pressure (IOP) rise.
* Currently on medication for ocular hypertension or glaucoma in the study eye.
* Diabetes.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
timeFrame: Day 15 ± 2 days
Secondary outcomes:
measure: Global Assessment Score of Postoperative Inflammation by Visit
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
measure: Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
timeFrame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References: