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A Comparison of Three Different Formulations of Prednisolone Acetate 1%

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 27, 2006
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ( Indiana University School of Medicine ):

Primary Outcome Measures:
  • Percent Change in Flare at Resolution [ Time Frame: 2 months ]

Enrollment: 60
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: 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 Name: 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 Name: 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

Detailed Description:

Overall Study Design:


This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.


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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345046

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

Additional Information:
Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. Review.
Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987 Oct;123(10):1312-4.
Olsen EA. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Arch Dermatol. 1991 Feb;127(2):197-201.
Casale TB, Azzam SM, Miller RE, Oren J. Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis. SAR Study Group. Ann Allergy Asthma Immunol. 1999 May;82(5):435-41.
Nell H, Louw CM, Cyster H, Williams Z, Bardin PG, Joubert JR. Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients. S Afr Med J. 2001 Jan;91(1):51-6.
Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979 Feb;87(2):210-4.
Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. German.
Shah SM, Spalton DJ, Taylor JC. Correlations between laser flare measurements and anterior chamber protein concentrations. Invest Ophthalmol Vis Sci. 1992 Sep;33(10):2878-84.
Fiscella RG, Gutta R, Goldstein DB, Viana MAG. Comparison of PredForte Brand to generic Prednisolone acette and loteprednol etabonate (lotemax) in a Rabbit Model of Inflammation. American Academy of Ophthalmology 2001 Annual Meeting, Poster 73 Session 2001.

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00345046     History of Changes
Other Study ID Numbers: 0201-28
First Submitted: June 26, 2006
First Posted: June 27, 2006
Results First Submitted: December 24, 2013
Results First Posted: April 21, 2014
Last Update Posted: June 3, 2015
Last Verified: March 2014

Keywords provided by Indiana University ( Indiana University School of Medicine ):

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

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