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Clinical Trials/NCT01124045
NCT01124045CompletedPhase 3

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

Alcon Research1 site in 1 country80 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Experimental

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

Active Comparator

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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