Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

Sandoz

Status and phase: Completed; Phase 1

Conditions: Inflammation Following Ocular Surgery

Treatments: Drug: Generic Loteprednol Etabonate; Drug: Reference Listed Drug (RLD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03531697

SAN-LE-002

Details and patient eligibility

About

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

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

381 participants in 2 patient groups

Generic Loteprednol Etabonate - RLD

Experimental group

Description:

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

Treatment:

Drug: Generic Loteprednol Etabonate

Drug: Reference Listed Drug (RLD)

RLD - Generic Loteprednol Etabonate

Active Comparator group

Description:

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

Treatment:

Drug: Generic Loteprednol Etabonate

Drug: Reference Listed Drug (RLD)