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KPI-121 1% Versus Prednisolone for the Treatment of 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: NCT03596723
Recruitment Status : Terminated (NDA #210565 did not trigger the need for a Pediatric Research Equity Act/PREA study.)
First Posted : July 24, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief Summary:
This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.

Condition or disease Intervention/treatment Phase
Ocular Inflammation Drug: KPI-121 1% Drug: Prednisolone acetate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : October 18, 2018


Arm Intervention/treatment
Experimental: KPI-121 1% BID Drug: KPI-121 1%
eye drops

Active Comparator: Prednisolone acetate QID Drug: Prednisolone acetate
eye drops
Other Name: Pred Forte




Primary Outcome Measures :
  1. Anterior chamber cell grade [ Time Frame: Day 15 ]
    Anterior chamber cell grade = 0. Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. The anterior chamber cell grading is whole numbers from 0 (no cells) to 4 (> 30 cells). Higher values indicate greater inflammation.


Secondary Outcome Measures :
  1. Modified Global Overall Assessment of Postoperative Inflammation [ Time Frame: Day 15 ]
    Modified Global Overall Assessment of Postoperative Inflammation score = 0. The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. The Modified Global Assessment grading is whole numbers from 0 (clear) to 3 (not improving or worsening). Lower values indicate greater healing.



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a candidate for routine, uncomplicated cataract surgery

Exclusion Criteria:

  • Have a post-traumatic cataract.
  • Have suspected permanent low vision or blindness in the fellow non-study eye.
  • Have active uveitis in either eye.
  • Have an ocular neoplasm in either eye.
  • Have the presence of viral, bacterial, or fungal disease in either eye.
  • Have glaucoma, ocular hypertension, steroid-induced IOP rise or elevated IOP

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): NCT03596723


Locations
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United States, California
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303
United States, Michigan
Children's Eye Care, PC
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Pediatric Ophthalmology of Erie, Inc.
Erie, Pennsylvania, United States, 16501
United States, Texas
Houston Eye Associates
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.

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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03596723     History of Changes
Other Study ID Numbers: KPI-121-C-010
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Eye Diseases
Inflammation
Pathologic Processes
Lens Diseases
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