Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

NCT ID: NCT00699153

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-06-30

Brief Summary

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Conditions

Ocular Inflammation

Study Design

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

Study Groups

Loteprednol Etabonate

Loteprednol Etabonate 0.5%

Group Type: EXPERIMENTAL

Loteprednol Etabonate

Intervention Type: DRUG

Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.

Vehicle

Vehicle of Ophthalmic Loteprednol Etabonate

Group Type: PLACEBO_COMPARATOR

Vehicle of Ophthalmic Loteprednol Etabonate

Intervention Type: DRUG

Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Interventions

Loteprednol Etabonate

Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.

Intervention Type: DRUG

Vehicle of Ophthalmic Loteprednol Etabonate

Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects at least 18 years of age
• Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Subjects who are candidate for routine, uncomplicated cataract surgery.
• Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
• Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion Criteria

• Subjects who have known hypersensitivity or contraindication to the study drug or its components.
• Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
• Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
• Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
• Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
• Women who are pregnant or breast feeding.
• Subjects who have participated in an investigational drug or device study within the last 30 days.
• Subjects previously randomized in this study.

• 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

Laura Trusso

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Cornerstone Eye Wear

High Point, North Carolina, United States

Countries

United States

Other Identifiers

526

Identifier Type: -

Identifier Source: org_study_id