Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT ID: NCT02208297

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-03-31

Brief Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Detailed Description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Conditions

Inflammation; Pain; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Loteprednol Etabonate Gel (BID)

Loteprednol Etabonate Gel 0.38% administered two times daily (BID)

Group Type: EXPERIMENTAL

Loteprednol Etabonate Gel (BID)

Intervention Type: DRUG

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

Vehicle Gel (BID)

Vehicle gel administered two times daily (BID)

Group Type: PLACEBO_COMPARATOR

Vehicle Gel (BID)

Intervention Type: DRUG

One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Interventions

Loteprednol Etabonate Gel (BID)

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

Intervention Type: DRUG

Vehicle Gel (BID)

One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Intervention Type: DRUG

Other Intervention Names

Lotemax; Vehicle

Eligibility Criteria

Inclusion Criteria

Visit 1 (Screening Visit)

• Be willing and able to comply with all treatment and follow-up/study procedures.
• Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

• Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
• Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria

• Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
• Have known hypersensitivity or contraindication to the study drug(s) or their components.

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

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Vittitow

Role: STUDY_DIRECTOR

Valeant/Bausch & Lomb

Locations

Bausch & Lomb Incorporated

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

843

Identifier Type: -

Identifier Source: org_study_id