LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-01

Brief Summary

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Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

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Detailed Description

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A Phase 3, Multi-Center, Double-Masked, Vehicle Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Conditions

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Cataract Pain Ocular Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Loteprednol Etabonate Ophthalmic Gel dosed TID

Gel

Group Type EXPERIMENTAL

Loteprednol Etabonate Ophthalmic Gel dosed TID

Intervention Type DRUG

Gel

Loteprednol Etabonate Ophthalmic Gel dosed BID

Gel

Group Type EXPERIMENTAL

Loteprednol Etabonate Ophthalmic Gel dosed BID

Intervention Type DRUG

Gel

Vehicle Gel

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type DRUG

Gel

Interventions

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Loteprednol Etabonate Ophthalmic Gel dosed TID

Gel

Intervention Type DRUG

Loteprednol Etabonate Ophthalmic Gel dosed BID

Gel

Intervention Type DRUG

Vehicle Gel

Gel

Intervention Type DRUG

Other Intervention Names

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LE LE Vehicle

Eligibility Criteria

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Inclusion Criteria

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
2. Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
3. Be willing and able to comply with all treatment and follow-up/study procedures.
4. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens \[IOL\] implantation, not combined with any other surgery).
5. In the Investigator's opinion, have potential postoperative pin-holed Snellen visual acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least 20/200 in the fellow eye.

Exclusion Criteria

1. Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
2. Be a female subject who is pregnant or breastfeeding.
3. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200).
4. Have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No