NCT00198523

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

September 13, 2005

Last Update Submit

March 13, 2013

Conditions

Eye InfectionsPostoperative Complications

Keywords

Cataract ExtractionAnti-Bacterial AgentsSteroids

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points

    Comparison of aqueous humor concentrations of prednisolone acetate at various time points

    2 days

Study Arms (2)

Prednisolone and Tobramycin

EXPERIMENTAL

Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.

Drug: Prednisolone and Tobramycin

Prednisolone

ACTIVE COMPARATOR

Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.

Drug: Prednisolone

Interventions

Prednisolone and TobramycinDRUG
Prednisolone and Tobramycin
PrednisoloneDRUG
Also known as: Pred Forte
Prednisolone

Eligibility Criteria

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

You may qualify if:

  • Bilateral cataract surgery
  • Avoid disallowed medications throughout study

You may not qualify if:

  • Contraindications to the use of the test agents
  • Known allergy or sensitivity to the test agents or components
  • History of steroid response following topical administration of corticosteroids in the eye
  • Wore contact lenses 48 hours prior to Visit 1
  • An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
  • Any significant illness that could be expected to interfere with study
  • Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Donald E. Beahm, MD

Great Bend, Kansas, 67530, United States

Location

Cornea Consultants/Laser Eye Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Great Lakes Eye Care

Saint Joseph, Michigan, 49085, United States

Location

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire, 03801, United States

Location

Texan Eye Care PA

Austin, Texas, 78705, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

MeSH Terms

Conditions

Eye InfectionsPostoperative Complications

Interventions

PrednisoloneTobramycinprednisolone acetate

Condition Hierarchy (Ancestors)

InfectionsEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsNebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Tim McNamara, PharmD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(6)