A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198523

Enrollment

132

Registered

2005-09-20

Start date

2005-07-31

Completion date

2005-10-31

Last updated

2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Infections, Postoperative Complications

Keywords

Cataract Extraction, Anti-Bacterial Agents, Steroids

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.

Interventions

DRUGPrednisolone and Tobramycin

DRUGPrednisolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Bilateral cataract surgery * Avoid disallowed medications throughout study

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points	2 days	Comparison of aqueous humor concentrations of prednisolone acetate at various time points

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026