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: April 8, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Glaucoma
Cataract
Drug: Pred Forte
Drug: EconoPred Plus
Drug: Prednisolone Acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Steroid time to resolution of flare. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: September 2002
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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:
  • Pred Forte
  • Econopred Plus
Active Comparator: 2
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 Name: Pred Forte
Active Comparator: 3
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345046

Locations
United States, Indiana
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
  More Information

Publications:
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00345046     History of Changes
Other Study ID Numbers: 0201-28
Study First Received: June 26, 2006
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Glaucoma
Cataract

Additional relevant MeSH terms:
Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014