A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Completed · Phase 4

Conditions studied: Glaucoma, Cataract

In brief

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

Key facts

Study ID

NCT00345046

Run by

Indiana University

People needed

60

Starts

2002-09-01

Expected to finish

2011-09-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• IU Eye at Carmel — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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