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Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT02208297 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2020-09-25

Study results available
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Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Conditions

Interventions

DRUG

Loteprednol Etabonate Gel (BID)

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

DRUG

Vehicle Gel (BID)

One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Jason Vittitow · Valeant/Bausch & Lomb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208297 on ClinicalTrials.gov