Back to resultsStudy of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Primary Purpose
Inflammation Following Ocular Surgery
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Generic Loteprednol Etabonate
Reference Listed Drug (RLD)
Sponsored by
About this trial
This is an interventional other trial for Inflammation Following Ocular Surgery focused on measuring 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.
Sites / Locations
- Sandoz Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Generic Loteprednol Etabonate - RLD
RLD - Generic Loteprednol Etabonate
Arm Description
Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)
Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate
Outcomes
Primary Outcome Measures
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03531697
Brief Title
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Official Title
A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
September 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Following Ocular Surgery
Keywords
Loteprednol Etabonate
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Generic Loteprednol Etabonate - RLD
Arm Type
Experimental
Arm Description
Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)
Arm Title
RLD - Generic Loteprednol Etabonate
Arm Type
Active Comparator
Arm Description
Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate
Intervention Type
Drug
Intervention Name(s)
Generic Loteprednol Etabonate
Intervention Description
Drug
Intervention Type
Drug
Intervention Name(s)
Reference Listed Drug (RLD)
Other Intervention Name(s)
Loteprednol Etabonate
Intervention Description
Drug
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
Description
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
Time Frame
upon study completion, up to 1 year
Title
Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)
Description
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
Time Frame
upon study completion, up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz
Organizational Affiliation
Sandoz
Official's Role
Study Director
Facility Information:
Facility Name
Sandoz Investigative Site
City
Multiple Locations
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
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