a comparison of three different formulations of prednisolone acetate 1%

Conditions: Glaucoma; Cataract

Summary: generic prednisolone acetate 1% is less effective than pred forte 1% or econopred plus 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.

Eligibility criteria:
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

Keywords: glaucoma cataract