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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Loteprednol etabonate
Prednisolones acetate
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Pediatric cataract

Eligibility Criteria

undefined - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Loteprednol etabonate

Prednisolones acetate

Arm Description

Loteprednol etabonate 0.5%

Prednisolone acetate 1.0%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2011
Last Updated
June 10, 2019
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01475643
Brief Title
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Pediatric cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol etabonate
Arm Type
Experimental
Arm Description
Loteprednol etabonate 0.5%
Arm Title
Prednisolones acetate
Arm Type
Active Comparator
Arm Description
Prednisolone acetate 1.0%
Intervention Type
Drug
Intervention Name(s)
Loteprednol etabonate
Other Intervention Name(s)
LE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolones acetate
Other Intervention Name(s)
PA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anterior Chamber Inflammation
Description
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
Time Frame
Postoperative Day 29
Secondary Outcome Measure Information:
Title
Anterior Chamber Cells & Flare
Description
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
Time Frame
Over all visits 42 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Valeant/Bausch & Lomb
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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