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.
Brief Title
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cataract
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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* Subject is a candidate for routine, uncomplicated surgery for childhood cataract
* Subject is a candidate for routine, uncomplicated surgery for childhood cataract
Gender
All
Gender Based
false
Keywords
Pediatric cataract
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
11 Years
NCT Id
NCT01475643
Org Class
Industry
Org Full Name
Bausch & Lomb Incorporated
Org Study Id
670
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome 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
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
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
Outcome Measure
Anterior Chamber Inflammation
Outcome Time Frame
Postoperative Day 29
Secondary Outcomes
Outcome 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
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
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
Outcome Time Frame
Over all visits 42 days
Outcome Measure
Anterior Chamber Cells & Flare
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
11
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Norman Medow
Investigator Email
nmedow@montefiore.org
Investigator Phone