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Study of T-PRED(TM) Compared to Pred Forte(R)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T-PRED
Pred Forte
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age

Exclusion Criteria:

  • No active or adverse disease

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

T-Pred

Pred Forte

Arm Description

Tobramycin prednisolone acetate combination

Prednisolone acetate

Outcomes

Primary Outcome Measures

Mean Aqueous Humor Prednisolone Acetate Concentration

Secondary Outcome Measures

Full Information

First Posted
June 16, 2008
Last Updated
September 2, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00699803
Brief Title
Study of T-PRED(TM) Compared to Pred Forte(R)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of T-PRED(TM) compared to Pred Forte(R)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-Pred
Arm Type
Active Comparator
Arm Description
Tobramycin prednisolone acetate combination
Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
Prednisolone acetate
Intervention Type
Drug
Intervention Name(s)
T-PRED
Intervention Description
T-PRED sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Intervention Description
Pred Forte sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Aqueous Humor Prednisolone Acetate Concentration
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age Exclusion Criteria: No active or adverse disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of T-PRED(TM) Compared to Pred Forte(R)

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