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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: February 26, 2009
Last updated: April 4, 2014
Last verified: April 2014

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

Condition Intervention Phase
Drug: T-Pred
Drug: Pred Forte
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ratio of means aqueous humor prednisolone acetate concentrations [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-Pred
Tobramycin prednisolone acetate combination
Drug: T-Pred
sterile ophthalmic solution
Active Comparator: Pred Forte
Prednisolone acetate
Drug: Pred Forte
sterile ophthalmic solution


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

  • No active or adverse disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00854061

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00854061     History of Changes
Other Study ID Numbers: CL-PKT-0415083-P
Study First Received: February 26, 2009
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration processed this record on March 26, 2015