A Comparison of Three Different Formulations of Prednisolone Acetate 1%

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ClinicalTrials.gov Identifier: NCT00345046

Recruitment Status : Completed

First Posted : June 27, 2006

Results First Posted : April 21, 2014

Last Update Posted : June 3, 2015

Sponsor:

Information provided by (Responsible Party):

Indiana University ( Indiana University School of Medicine )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Glaucoma Cataract	Drug: Pred Forte Drug: EconoPred Plus Drug: Prednisolone Acetate	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
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.
Study Start Date :	September 2002
Actual Primary Completion Date :	September 2011
Actual Study Completion Date :	September 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

Percent Change in Flare at Resolution [ Time Frame: 2 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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

Locations

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

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

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Principal Investigator:	Louis B Cantor, MD	IUPUI/Clarian

More Information

Additional Information:

Electronic Orange Book This link exits the ClinicalTrials.gov site

Publications:

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.

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Responsible Party:	Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00345046
Other Study ID Numbers:	0201-28
First Posted:	June 27, 2006 Key Record Dates
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 ):


Glaucoma Cataract

Additional relevant MeSH terms:

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Glaucoma Cataract Ocular Hypertension Eye Diseases Lens Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisone Prednisolone hemisuccinate Prednisolone phosphate	Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents

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