A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Condition(s) targeted: Glaucoma; Cataract

Intervention: Pred Forte (Drug); EconoPred Plus (Drug); Prednisolone Acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Louis B Cantor, MD, Principal Investigator, Affiliation: IUPUI/Clarian

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

Official title: A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change in Flare at Resolution

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Electronic Orange Book

Related 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.

Starting date: September 2002
Last updated: June 2, 2015