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: Recruiting

Sponsored by: Indiana University School of Medicine

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

Overall contact:
Joni S Hoop, CCRC, Phone: 317-274-2745, Email: jhoop@iupui.edu

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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Bio-equivalence Study

Primary outcome: Steroid time to resolution of flare.

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:

- All subjects must:

- 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:

- No subject may:

- Have any contraindication to use of corticosteroids.

- Have any active 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.

- Have 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

6. Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.

7. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.

8. 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).

9. 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

Joni S Hoop, CCRC, Phone: 317-274-2745, Email: jhoop@iupui.edu

IU Eye at Carmel, Indianapolis, Indiana 46290, United States; Recruiting
Louis B Cantor, MD, Principal Investigator
Darrell WuDunn, MD, Sub-Investigator
Yara P Catoira, MD, Sub-Investigator
Chi-Wah Yung, MD, Sub-Investigator

Related 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.

Starting date: September 2002
Ending date: December 2012
Last updated: August 4, 2008