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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DUREZOL
Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day 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
Intervention: Difluprednate ophthalmic emulsion, 0.05% (Drug)
PRED FORTE
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day 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
Intervention: Prednisolone acetate ophthalmic suspension, 1.0% (Drug)
Outcomes
Primary Outcomes
Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
Time Frame: Day 15 ± 2 days
Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.
Secondary Outcomes
- Global Assessment Score of Postoperative Inflammation by Visit(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia(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)
- Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation(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)