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

NCT01475643 | Completed Phase 3 Results

• 1 other identifier: 670
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Pediatric cataract

Outcome Measures

Primary Outcomes (1)

• 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 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

  Postoperative Day 29

Secondary Outcomes (1)

• Anterior Chamber Cells & Flare

  Over all visits 42 days

Study Arms (2)

Loteprednol etabonate

EXPERIMENTAL

Loteprednol etabonate 0.5%

Drug: Loteprednol etabonate

Prednisolones acetate

ACTIVE COMPARATOR

Prednisolone acetate 1.0%

Drug: Prednisolones acetate

Interventions

Loteprednol etabonate DRUG

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.

Also known as: LE

Loteprednol etabonate

Prednisolones acetate DRUG

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.

Also known as: PA

Prednisolones acetate

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is a candidate for routine, uncomplicated surgery for childhood cataract

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Inc

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Denise Raimondo
• Organization: Valeant Pharmaceuticals NA

denise.raimondo@valeant.com

9089721885

Study Officials

• Johnson Varughese

  Valeant/Bausch & Lomb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: June 1, 2013
• Primary Completion: June 2, 2017
• Study Completion: July 1, 2017
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-06

Locations

US (1)