Trials / Completed
CompletedNCT00198523
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (planned)
- Sponsor
- Bausch & Lomb Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prednisolone and Tobramycin | |
| DRUG | Prednisolone |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2005-10-01
- Completion
- 2005-10-01
- First posted
- 2005-09-20
- Last updated
- 2013-03-15
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00198523. Inclusion in this directory is not an endorsement.