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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475643
• Other study ID #: 670
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: July 2017

Study information

• Verified date: June 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Uveitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Bausch & Lomb Inc	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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