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

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ClinicalTrials.gov Identifier: NCT01475643
Recruitment Status : Active, not recruiting
First Posted : November 21, 2011
Last Update Posted : April 26, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 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
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 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 ]
    Mean grade of converted anterior chamber inflammation


Secondary Outcome Measures :
  1. Anterior Chamber Cells & Flare [ Time Frame: Over all visits 42 days ]
    Proportion of subjects with anterior chamber inflammation.



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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
United States, New York
Bausch & Lomb Inc
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Johnson Varughese Valeant/Bausch & Lomb

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01475643     History of Changes
Other Study ID Numbers: 670
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Bausch & Lomb Incorporated:
Pediatric cataract

Additional relevant MeSH terms:
Inflammation
Cataract
Uveitis
Pathologic Processes
Lens Diseases
Eye Diseases
Uveal Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol Etabonate
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