NCT00854061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

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

February 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

February 26, 2009

Results QC Date

August 18, 2020

Last Update Submit

October 16, 2020

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Means Aqueous Humor Prednisolone Acetate Concentration

    35 days

Study Arms (2)

T-Pred

EXPERIMENTAL

Tobramycin prednisolone acetate combination

Drug: T-Pred

Pred Forte

ACTIVE COMPARATOR

Prednisolone acetate

Drug: Pred Forte

Interventions

T-PredDRUG

sterile ophthalmic solution

T-Pred
Pred ForteDRUG

sterile ophthalmic solution

Pred Forte

Eligibility Criteria

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

You may qualify if:

  • years of age or older

You may not qualify if:

  • No active or adverse disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

prednisolone acetate

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Tim McNamara, PharmD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2009

First Posted

March 2, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-10

Locations

US(1)