A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345046
• Other study ID #: 0201-28
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2006
• Last updated: June 2, 2015
• Start date: September 2002
• Est. completion date: September 2011

Study information

• Verified date: March 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Drug:
• Pred Forte
Four drops daily decreasing to once daily over four weeks.
• EconoPred Plus
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
• Prednisolone Acetate
Dosed four times daily decreasing to once daily over four weeks.

Locations

Country	Name	City	State
United States	IU Eye at Carmel	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (9)

Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979 Feb;87(2):210-4. — View Citation

Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. Review. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987 Oct;123(10):1312-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Flare at Resolution		2 months	No

External Links

•   Electronic Orange Book