Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

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

Study Overview

• Status: Completed
• Conditions: Inflammation Following Ocular Surgery
• Intervention / Treatment: Drug: Generic Loteprednol Etabonate; Drug: Reference Listed Drug (RLD)

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada
    • Sandoz Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
• Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control [condom or diaphragm and spermicide] for the duration of the study).
• Male subjects should use medically reliable contraception methods such as condom or vasectomy.
• Subjects are able to perform the activities required by the study protocol and have provided written informed consent.

Exclusion Criteria:

• Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
• Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
• Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
• Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
• Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Generic Loteprednol Etabonate - RLD; Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)	Drug: Generic Loteprednol Etabonate; Drug; Drug: Reference Listed Drug (RLD); Drug; Other Names: Loteprednol Etabonate
Active Comparator: RLD - Generic Loteprednol Etabonate; Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate	Drug: Generic Loteprednol Etabonate; Drug; Drug: Reference Listed Drug (RLD); Drug; Other Names: Loteprednol Etabonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)	PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.	upon study completion, up to 1 year
Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)	PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.	upon study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Actual): September 7, 2019
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Loteprednol Etabonate
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: SAN-LE-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes