A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Overall Study Design:

Structure:

This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.

Duration:

Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. One hundred and two subjects will be enrolled over a twelve-month time span.

Controls:

Examiner, staff, and subjects are masked. Parallel group comparison.

Dosage/Dose Regimen/Instructions:

Subjects scheduled for glaucoma and/or cataract surgery will be recruited. Subjects may not be currently on any steroid or ophthalmic non-steroidal anti-inflammatory (NSAID) therapy for a minimum of 6 weeks prior to surgery. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. After 1 month of therapy subjects will stop or continue steroid treatment based on clinical findings. No other subconjunctival steroid or ointment will be used intra-operatively or post-operatively. The eye drop will be instilled per labeling instructions.

Inclusion criteria

• Be willing and able to provide written informed consent.
• Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study.
• Be male or female of any race at least 18 years of age.
• Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.

Exclusion criteria

• Contraindication to use of corticosteroids.
• Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
• Laser or any other intraocular surgery within the past three months.
• Require use of ocular NSAID or systemic steroids.
• Have known allergy or sensitivity to the study medications or their components
• Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
• Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
• Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
• Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study