A Comparison of Three Different Formulations of Prednisolone Acetate 1%

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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