NCT00345046

A Comparison of Three Different Formulations of Prednisolone Acetate 1%

A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.

Detailed description

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.

Conditions

• Glaucoma
• Cataract

Interventions

Type	Name	Description
DRUG	Pred Forte	Four drops daily decreasing to once daily over four weeks.
DRUG	EconoPred Plus	Prednisolone Acetate four times daily decreasing to once daily over four weeks.
DRUG	Prednisolone Acetate	Dosed four times daily decreasing to once daily over four weeks.

Timeline

• Start date: 2002-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2006-06-27
• Last updated: 2015-06-03
• Results posted: 2014-04-21

Locations

1 site across 1 country: United States