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

Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract

The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Loteprednol etabonate; Drug: Prednisolones acetate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: LE
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.; Other Names: PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Inflammation	Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal; = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal; = Moderate Moderate anterior chamber clouding; = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished; = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished	Postoperative Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Cells & Flare	Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect; = Mild Tyndall effect barely discernible; = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly; = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly; = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance	Over all visits 42 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Johnson Varughese, Valeant/Bausch & Lomb

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2013
• Primary Completion (ACTUAL): June 2, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (ESTIMATE): November 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric cataract
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Lens Diseases; Inflammation; Cataract; Uveitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anti-Allergic Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Loteprednol Etabonate
• Other Study ID Numbers: 670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED