KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2018-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Ocular Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KPI-121 1% BID (twice daily)

Group Type EXPERIMENTAL

KPI-121 1%

Intervention Type DRUG

eye drops

Prednisolone acetate QID (four times daily)

Group Type ACTIVE_COMPARATOR

Prednisolone acetate

Intervention Type DRUG

eye drops

Interventions

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KPI-121 1%

eye drops

Intervention Type DRUG

Prednisolone acetate

eye drops

Intervention Type DRUG

Other Intervention Names

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Pred Forte

Eligibility Criteria

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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 (intraocular pressure) rise or elevated IOP

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No