Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

NCT ID: NCT03531697

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2019-10-07

Brief Summary

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

Conditions

Inflammation Following Ocular Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Generic Loteprednol Etabonate - RLD

Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)

Group Type: EXPERIMENTAL

Generic Loteprednol Etabonate

Intervention Type: DRUG

Drug

Reference Listed Drug (RLD)

Intervention Type: DRUG

Drug

RLD - Generic Loteprednol Etabonate

Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate

Group Type: ACTIVE_COMPARATOR

Generic Loteprednol Etabonate

Intervention Type: DRUG

Drug

Reference Listed Drug (RLD)

Intervention Type: DRUG

Drug

Interventions

Generic Loteprednol Etabonate

Drug

Intervention Type: DRUG

Reference Listed Drug (RLD)

Drug

Intervention Type: DRUG

Other Intervention Names

Loteprednol Etabonate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

Sandoz Investigative Site

Multiple Locations, , Canada

Countries

Canada

Other Identifiers

SAN-LE-002

Identifier Type: -

Identifier Source: org_study_id