NCT00345046

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 21, 2014

Completed
Last Updated

June 3, 2015

Status Verified

March 1, 2014

Enrollment Period

9 years

First QC Date

June 26, 2006

Results QC Date

December 24, 2013

Last Update Submit

June 2, 2015

Conditions

GlaucomaCataract

Keywords

GlaucomaCataract

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Flare at Resolution

    2 months

Study Arms (3)

Pred Forte 1%

ACTIVE COMPARATOR

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

Drug: Pred Forte

EconoPred Plus 1%

ACTIVE COMPARATOR

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

Drug: EconoPred Plus

Prednisolone Acetate 1%

ACTIVE COMPARATOR

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

Drug: Prednisolone Acetate

Interventions

Pred ForteDRUG

Four drops daily decreasing to once daily over four weeks.

Also known as: Econopred Plus
Pred Forte 1%
EconoPred PlusDRUG

Prednisolone Acetate four times daily decreasing to once daily over four weeks.

Also known as: Pred Forte
EconoPred Plus 1%
Prednisolone AcetateDRUG

Dosed four times daily decreasing to once daily over four weeks.

Also known as: Pred Forte, EconoPred Plus
Prednisolone Acetate 1%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Eye at Carmel

Indianapolis, Indiana, 46290, United States

Location

Related Publications (9)

  • 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.

    PMID: 9327353BACKGROUND

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

    PMID: 3662563BACKGROUND

  • 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.

    PMID: 1990984BACKGROUND

  • 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.

    PMID: 10353573BACKGROUND

  • 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.

    PMID: 11236299BACKGROUND

  • 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.

    PMID: 434075BACKGROUND

  • 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.

    PMID: 11220271BACKGROUND

  • 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.

    PMID: 1526738BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

GlaucomaCataract

Interventions

prednisolone acetateMethylprednisolone

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Louis B. Cantor
Organization
Indiana University
lcantor@iupui.edu
317-278-2651

Study Officials

  • Louis B Cantor, MD

    IUPUI/Clarian

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

September 1, 2002

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 3, 2015

Results First Posted

April 21, 2014

Record last verified: 2014-03

Locations

US(1)