A Comparison of Three Different Formulations of Prednisolone Acetate 1% - Full Text View

Sponsor:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00345046

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 IV

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate 16-Methyleneprednisolone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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 ]

Estimated Enrollment:	102
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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:

Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. Review. No abstract available.

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. No abstract available.

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.

Responsible Party:	Louis B. Cantor, M.D., Indiana University
ClinicalTrials.gov Identifier:	NCT00345046 History of Changes
Other Study ID Numbers:	0201-28
Study First Received:	June 26, 2006
Last Updated:	September 22, 2011
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 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 February 12, 2012