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NCT Number: NCT00198523

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

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.

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Key information

Conditions

Eye Infections Eye Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Donald E. Beahm, MD, Great Bend, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone and Tobramycin

Drug

Prednisolone

Drug

Other names: Pred Forte

Primary outcomes

  1. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points

    Time frame: 2 days

    Comparison of aqueous humor concentrations of prednisolone acetate at various time points

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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