A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
Completed
Novartis
Phase 4
2004-08-01
The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye
drops by testing the hypothesis that the ocular safety and tolerability of prednisolone
acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected
and have been treated by using a crossover design.
A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
Completed
Novartis
Phase 4
2004-08-17
The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone
acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the
anterior chamber of the operated eye.
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Completed
Bausch & Lomb Incorporated
Phase 3
2005-07-01
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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