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

NCT01996839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

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 ophthalmic gel

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

Loteprednol Etabonate Gel (TID)

One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.

DRUG

Vehicle (BID)

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

DRUG

Vehicle (TID)

One drop of vehicle instilled into the study eye three times per day (TID) for 14 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Jon I Williams, PhD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01996839 on ClinicalTrials.gov