Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

Inflammation Following Ocular Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531697
• Other study ID #: SAN-LE-002
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: October 7, 2019

Study information

• Verified date: November 2019
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: October 7, 2019
• Est. primary completion date: September 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Inflammation Following Ocular Surgery

Intervention

Drug:
• Generic Loteprednol Etabonate
Drug
• Reference Listed Drug (RLD)
Drug

Locations

Country	Name	City	State
Canada	Sandoz Investigative Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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