Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01124045
First received: May 13, 2010
Last updated: April 30, 2013
Last verified: April 2013

May 13, 2010
April 30, 2013
August 2010
April 2012   (final data collection date for primary outcome measure)
Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days [ Time Frame: Day 15 ± 2 days ] [ Designated as safety issue: No ]
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.
  • Number of patients with anterior cell grade of 0 (no cells) [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Frequency and incidence of adverse events [ Time Frame: Day 0 through 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01124045 on ClinicalTrials.gov Archive Site
  • Global Assessment Score of Postoperative Inflammation by Visit [ Time Frame: 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 ] [ Designated as safety issue: No ]
    A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Anterior chamber 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. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) 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. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
  • Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Global assessment score of post-operative inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cataracts
  • Inflammation
  • Drug: Difluprednate ophthalmic emulsion, 0.05%
    Topical ocular administration
    Other Name: DUREZOL™
  • Drug: Prednisolone acetate ophthalmic suspension, 1.0%
    Topical ocular administration
    Other Name: PRED FORTE™
  • Experimental: 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: Drug: Difluprednate ophthalmic emulsion, 0.05%
  • Active Comparator: 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: Drug: Prednisolone acetate ophthalmic suspension, 1.0%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
up to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01124045
C-10-004
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP