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

Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Pred Forte
  • Four drops daily decreasing to once daily over four weeks.
• Drug: EconoPred Plus
  • Prednisolone Acetate four times daily decreasing to once daily over four weeks.
• Drug: Prednisolone Acetate
  • Dosed four times daily decreasing to once daily over four weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
• Active Comparator: 2
  • EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
• Active Comparator: 3
  • Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Primary Measures

• Steroid time to resolution of flare.
  • Time Frame: 2 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Indiana University School of Medicine

Overall Clinical Trial Officials and Contacts

Louis B Cantor, MD Principal Investigator IUPUI/Clarian  

Overall Contact: Joni S Hoop, CCRC 317-274-2745 jhoop@iupui.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00345046

Study ID Number: 0201-28

ClinicalTrials.gov Identifier: NCT00345046

Health Authority: United States: Institutional Review Board