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

NCT01124045 | Completed Phase 3 Results

• 1 other identifier: C-10-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts; Inflammation

Keywords

Pediatric; Cataracts; Inflammation; Durezol; Pred Forte; Difluprednate; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at 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.

  Day 15 ± 2 days

Secondary Outcomes (12)

• 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

Study Arms (2)

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

Drug: Difluprednate ophthalmic emulsion, 0.05%

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

Drug: Prednisolone acetate ophthalmic suspension, 1.0%

Interventions

Difluprednate ophthalmic emulsion, 0.05% DRUG

Topical ocular administration

Also known as: DUREZOL™

DUREZOL

Prednisolone acetate ophthalmic suspension, 1.0% DRUG

Topical ocular administration

Also known as: PRED FORTE™

PRED FORTE

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract; Inflammation

Interventions

difluprednate; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pam Kaur, PhD
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 19, 2013
• Results First Posted: June 19, 2013

Record last verified: 2013-04

Locations

US (1)