A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Study Overview
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Brief Summary
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Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.

Detailed Description
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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.

Official Title
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A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.

Conditions
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Glaucoma, Cataract

Intervention / Treatment
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* Drug: Pred Forte
* Drug: EconoPred Plus
* Drug: Prednisolone Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pred Forte 1%<br>Pred Forte 1% dosed four times daily decreasing to once daily over four weeks. | Drug: Pred Forte<br>* Four drops daily decreasing to once daily over four weeks.<br>* Other names: Econopred Plus;|
| Active Comparator: EconoPred Plus 1%<br>EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. | Drug: EconoPred Plus<br>* Prednisolone Acetate four times daily decreasing to once daily over four weeks.<br>* Other names: Pred Forte;|
| Active Comparator: Prednisolone Acetate 1%<br>Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks. | Drug: Prednisolone Acetate<br>* Dosed four times daily decreasing to once daily over four weeks.<br>* Other names: EconoPred Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Flare at Resolution |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Cataract