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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

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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


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475643


Locations
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United States, New York
Bausch & Lomb Inc
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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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

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01475643    
Other Study ID Numbers: 670
First Posted: November 21, 2011    Key Record Dates
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:
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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