MedTrace Logo

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

NCT03063489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-02-24

No results posted yet for this study

Summary

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers

Conditions

  • Eye Pain

Interventions

DRUG

Loteprednol Etabonate Ophthalmic Gel

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Denise Ramjit · Valeant Pharmaceuticals

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT03063489 on ClinicalTrials.gov