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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: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to compare the safety and efficacy of difluprednate and prednisolone acetate for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.


Condition Intervention Phase
Inflammation Following Cataract Surgery
 Drug: Difluprednate 0.05% ophthalmic emulsion
Drug: Prednisolone acetate 1.0% ophthalmic suspension
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Frequency and incidence of adverse events [ Time Frame: Day 0 through 3 months ] [ Designated as safety issue: Yes ]
  • Number of patients with anterior cell grade of 0 (no cells) [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global assessment score of post-operative inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Difluprednate 0.05%
Difluprednate 0.05% ophthalmic emulsion
 Drug: Difluprednate 0.05% ophthalmic emulsion
1 drop in study eye 4 times daily for 14 days followed by a 14 day tapering period.
Active Comparator: Prednisolone acetate 1.0%
Prednisolone acetate 1.0% ophthalmic suspension
 Drug: Prednisolone acetate 1.0% ophthalmic suspension
1 drop in study eye 4 times daily for 14 days followed by a 14 day tapering period.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 0 to 3 years of age.
  2. Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens
  3. Informed consent signed by a parent or legal guardian.

Exclusion Criteria:

  1. Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
  2. 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.
  3. Patients with posttraumatic cataract.
  4. Active uveitis in the study eye.
  5. Ocular neoplasm in the study eye.
  6. Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS)
  7. Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
  8. Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
  9. History of steroid-induced intraocular pressure (IOP) rise.
  10. Currently on medication for ocular hypertension or glaucoma in the study eye.
  11. Diabetes.
  12. Contact lens wear during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124045

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01124045     History of Changes
Other Study ID Numbers: C-10-004
Study First Received: May 13, 2010
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Fluprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Difluprednate
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013