A Comparison of Three Different Formulations of Prednisolone Acetate 1%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00345046
First received: June 26, 2006
Last updated: March 17, 2014
Last verified: March 2014

June 26, 2006
March 17, 2014
September 2002
September 2011   (final data collection date for primary outcome measure)
Percent Change in Flare at Resolution [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Steroid time to resolution of flare.
Complete list of historical versions of study NCT00345046 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Comparison of Three Different Formulations of Prednisolone Acetate 1%
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%.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Cataract
  • Drug: Pred Forte
    Four drops daily decreasing to once daily over four weeks.
    Other Names:
    • Pred Forte
    • Econopred Plus
  • Drug: EconoPred Plus
    Prednisolone Acetate four times daily decreasing to once daily over four weeks.
    Other Name: Pred Forte
  • Drug: Prednisolone Acetate
    Dosed four times daily decreasing to once daily over four weeks.
    Other Names:
    • Pred Forte
    • EconoPred Plus
  • Active Comparator: Pred Forte 1%
    Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
    Intervention: Drug: Pred Forte
  • Active Comparator: EconoPred Plus 1%
    EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
    Intervention: Drug: EconoPred Plus
  • Active Comparator: Prednisolone Acetate 1%
    Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
    Intervention: Drug: Prednisolone Acetate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345046
0201-28
No
Indiana University ( Indiana University School of Medicine )
Indiana University School of Medicine
Not Provided
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
Indiana University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP