Cataract Clinical Trial
Official title:
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
Overall Study Design:
Structure:
This is a randomized, double-masked prospective study. The study medications will be masked
and randomized by the outpatient pharmacy at Indiana University Hospital.
Duration:
Treatment duration: The duration of each subject's participation will be for up to 2 months
after surgery. One hundred and two subjects will be enrolled over a twelve-month time span.
Controls:
Examiner, staff, and subjects are masked. Parallel group comparison.
Dosage/Dose Regimen/Instructions:
Subjects scheduled for glaucoma and/or cataract surgery will be recruited. Subjects may not
be currently on any steroid or ophthalmic non-steroidal anti-inflammatory (NSAID) therapy
for a minimum of 6 weeks prior to surgery. Subjects will be randomized to receive a dose of
Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four
times a day starting immediately after finishing the surgery for two weeks, then twice a day
for two more weeks. After 1 month of therapy subjects will stop or continue steroid
treatment based on clinical findings. No other subconjunctival steroid or ointment will be
used intra-operatively or post-operatively. The eye drop will be instilled per labeling
instructions.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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