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Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

NCT03531697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2019-11-06

No results posted yet for this study

Summary

This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)

Conditions

  • Inflammation Following Ocular Surgery

Interventions

DRUG

Generic Loteprednol Etabonate

Drug

DRUG

Reference Listed Drug (RLD)

Drug

Sponsors & Collaborators

Principal Investigators

  • Sandoz · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2019-09-07
Completion
2019-10-07
FDA Drug
Yes

Countries

  • Canada

More Related Trials

Entities

Companies

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 NCT03531697 on ClinicalTrials.gov