Status:
COMPLETED
A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Glaucoma
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00345046
Start Date
September 1 2002
End Date
September 1 2011
Last Update
June 3 2015
Active Locations (1)
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1
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290