Conditions: Glaucoma Cataract
Keywords: Glaucoma Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Pred Forte 1% dosed four times daily decreasing to once daily over four weeks. arm 2: EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. arm 3: Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Interventions: intervention 1: Pred Forte intervention 2: EconoPred Plus intervention 3: Prednisolone Acetate
Intervention descriptions: intervention 1: Four drops daily decreasing to once daily over four weeks. intervention 2: Prednisolone Acetate four times daily decreasing to once daily over four weeks. intervention 3: Dosed four times daily decreasing to once daily over four weeks.

Protocol document: