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

• ClinicalTrials.gov Identifier: NCT01475643
• Recruitment Status: Completed
• First Posted: November 21, 2011
• Results First Posted: June 11, 2019
• Last Update Posted: June 11, 2019
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cataract	Drug: Loteprednol etabonate; Drug: Prednisolones acetate	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, 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
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: June 2, 2017
• Actual Study Completion Date: July 2017

Arms and Interventions

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 Name: 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 Name: PA

Outcome Measures

Primary Outcome Measures :

1. Anterior Chamber Inflammation [ Time Frame: Postoperative Day 29 ]

   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

   1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal
   2. = Moderate Moderate anterior chamber clouding
   3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished
   4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished

Secondary Outcome Measures :

1. Anterior Chamber Cells & Flare [ Time Frame: Over all visits 42 days ]

   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

   1. = Mild Tyndall effect barely discernible
   2. = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly
   3. = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly
   4. = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance

Eligibility Criteria

• Ages Eligible for Study: up to 11 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, New York

Bausch & Lomb Inc

Rochester, New York, United States, 14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Johnson Varughese; Valeant/Bausch & Lomb

  Study Documents (Full-Text)

Documents provided by Bausch & Lomb Incorporated:

Study Protocol  [PDF] May 22, 2013

Statistical Analysis Plan  [PDF] May 22, 2013

More Information

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01475643
• Other Study ID Numbers: 670
• First Posted: November 21, 2011
• Results First Posted: June 11, 2019
• Last Update Posted: June 11, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Bausch & Lomb Incorporated:

Pediatric cataract

Additional relevant MeSH terms:

Cataract; Uveitis; Inflammation; Pathologic Processes; Lens Diseases; Eye Diseases; Uveal Diseases; Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Anti-Allergic Agents