Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

NCT ID: NCT00645671

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-03-31

Brief Summary

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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% ophthalmic ointment

Group Type: EXPERIMENTAL

0.5% Loteprednol Etabonate Ophthalmic Ointment

Intervention Type: DRUG

1/2 inch ribbon four times a day for 14 days

Vehicle

Vehicle of loteprednol etabonate ointment

Group Type: PLACEBO_COMPARATOR

Vehicle of Loteprednol Etabonate Ophthalmic Ointment

Intervention Type: DRUG

1/2 inch ribbon four times a day for 14 days

Interventions

0.5% Loteprednol Etabonate Ophthalmic Ointment

1/2 inch ribbon four times a day for 14 days

Intervention Type: DRUG

Vehicle of Loteprednol Etabonate Ophthalmic Ointment

1/2 inch ribbon four times a day for 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects who are candidate for routine, uncomplicated cataract surgery

2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids

2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components

3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye

4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

• 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

Alyson J Berliner, MD/PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

John Hunkeler, MD

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

525

Identifier Type: -

Identifier Source: org_study_id