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

NCT ID: NCT01124045

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Cataracts; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Difluprednate ophthalmic emulsion, 0.05%

Intervention Type: DRUG

Topical ocular administration

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

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate ophthalmic suspension, 1.0%

Intervention Type: DRUG

Topical ocular administration

Interventions

Difluprednate ophthalmic emulsion, 0.05%

Topical ocular administration

Intervention Type: DRUG

Prednisolone acetate ophthalmic suspension, 1.0%

Topical ocular administration

Intervention Type: DRUG

Other Intervention Names

DUREZOL™; PRED FORTE™

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.

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.

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

C-10-004

Identifier Type: -

Identifier Source: org_study_id