A Comparison of Three Different Formulations of Prednisolone Acetate 1%

June 2, 2015 updated by: Indiana University School of Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • IU Eye at Carmel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pred Forte 1%
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Drug: Pred Forte
Four drops daily decreasing to once daily over four weeks.
Other Names:
  • Econopred Plus
Active Comparator: EconoPred Plus 1%
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
Drug: EconoPred Plus
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
Other Names:
  • Pred Forte
Active Comparator: Prednisolone Acetate 1%
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Drug: Prednisolone Acetate
Dosed four times daily decreasing to once daily over four weeks.
Other Names:
  • Pred Forte
  • EconoPred Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Flare at Resolution
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Louis B Cantor, MD, IUPUI/Clarian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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