search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
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 or older

Exclusion Criteria:

  • No active or adverse disease

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T-Pred

Pred Forte

Arm Description

Tobramycin prednisolone acetate combination

Prednisolone acetate

Outcomes

Primary Outcome Measures

Means Aqueous Humor Prednisolone Acetate Concentration

Secondary Outcome Measures

Full Information

First Posted
February 26, 2009
Last Updated
October 16, 2020
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT00854061
Brief Title
Study of T-PRED(TM) Compared to Pred Forte(R) II
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (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)
Detailed Description
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

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 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-Pred
Arm Type
Experimental
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
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Means Aqueous Humor Prednisolone Acetate Concentration
Time Frame
35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older 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) II

We'll reach out to this number within 24 hrs