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A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Primary Purpose

Glaucoma, Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pred Forte
EconoPred Plus
Prednisolone Acetate
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IU Eye at Carmel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pred Forte 1%

EconoPred Plus 1%

Prednisolone Acetate 1%

Arm Description

Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.

EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.

Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Outcomes

Primary Outcome Measures

Percent Change in Flare at Resolution

Secondary Outcome Measures

Full Information

First Posted
June 26, 2006
Last Updated
June 2, 2015
Sponsor
Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00345046
Brief Title
A Comparison of Three Different Formulations of Prednisolone Acetate 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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract
Keywords
Glaucoma, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pred Forte 1%
Arm Type
Active Comparator
Arm Description
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Arm Title
EconoPred Plus 1%
Arm Type
Active Comparator
Arm Description
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
Arm Title
Prednisolone Acetate 1%
Arm Type
Active Comparator
Arm Description
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Other Intervention Name(s)
Econopred Plus
Intervention Description
Four drops daily decreasing to once daily over four weeks.
Intervention Type
Drug
Intervention Name(s)
EconoPred Plus
Other Intervention Name(s)
Pred Forte
Intervention Description
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate
Other Intervention Name(s)
Pred Forte, EconoPred Plus
Intervention Description
Dosed four times daily decreasing to once daily over four weeks.
Primary Outcome Measure Information:
Title
Percent Change in Flare at Resolution
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Cantor, MD
Organizational Affiliation
IUPUI/Clarian
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Eye at Carmel
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9327353
Citation
Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. doi: 10.1097/00061198-199710000-00011. No abstract available.
Results Reference
background
PubMed Identifier
3662563
Citation
Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987 Oct;123(10):1312-4.
Results Reference
background
PubMed Identifier
1990984
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.
Results Reference
background
PubMed Identifier
10353573
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. doi: 10.1016/s1081-1206(10)62717-2.
Results Reference
background
PubMed Identifier
11236299
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.
Results Reference
background
PubMed Identifier
434075
Citation
Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979 Feb;87(2):210-4. doi: 10.1016/0002-9394(79)90145-4. No abstract available.
Results Reference
background
PubMed Identifier
11220271
Citation
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. doi: 10.1007/s003470170199. German.
Results Reference
background
PubMed Identifier
1526738
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.
Results Reference
background
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.
Results Reference
background
Links:
URL
https://www.fda.gov/cder/ob/default.htm
Description
Electronic Orange Book

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A Comparison of Three Different Formulations of Prednisolone Acetate 1%

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