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Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

This study is not yet open for participant recruitment.
Verified March 2013 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01475643
First received: November 17, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.


Condition Intervention Phase
Cataract
 Drug: Loteprednol etabonate
Drug: Prednisolones acetate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Anterior Chamber Inflammation [ Time Frame: Postoperative Day 29 ] [ Designated as safety issue: No ]
    Mean grade of converted anterior chamber inflammation


Secondary Outcome Measures:
  • Anterior Chamber Cells & Flare [ Time Frame: Over all visits 42 days ] [ Designated as safety issue: No ]
    Proportion of subjects with anterior chamber inflammation.


Estimated Enrollment: 170
Study Start Date: May 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol etabonate
Loteprednol etabonate 0.5%
 Drug: Loteprednol etabonate
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Active Comparator: Prednisolones acetate
Prednisolone acetate 1.0%
 Drug: Prednisolones acetate
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion Criteria:

  • Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
  • Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
  • Subjects with a history of steroid-induced IOP elevation in either eye.
  • Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475643

Contacts
Contact: Adrienne Rossi (973) 360-6467 Adrienne.rossi@bausch.com

Locations
United States, New York
Bausch & Lomb Inc Not yet recruiting
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Ken Harper, BS Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01475643     History of Changes
Other Study ID Numbers: 670
Study First Received: November 17, 2011
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Pediatric cataract

Additional relevant MeSH terms:
Inflammation
Chorioretinitis
Uveitis
Cataract
Pathologic Processes
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Lens Diseases
Methylprednisolone acetate
 Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 21, 2013