NCT00645671 - Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery | Crick

Overview

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Ocular Inflammation

Interventions

0.5% Loteprednol Etabonate Ophthalmic OintmentDRUG

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

Vehicle of Loteprednol Etabonate Ophthalmic OintmentDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

John Hunkeler, MD

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Time frame: Postoperative Day 8 (Visit 5)

Grade 0 for Pain

Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe

Time frame: Postoperative Day 8 (Visit 5)

Secondary Outcomes

Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Time frame: At each follow-up visit through day18 (Visit 7)

Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Time frame: Baseline and each follow-up visit through day18 (Visit 7)