Glaucoma, Cataract
Conditions
Keywords
Glaucoma, Cataract
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.
Interventions
DRUGPred Forte
Four drops daily decreasing to once daily over four weeks.
DRUGEconoPred Plus
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
DRUGPrednisolone Acetate
Dosed four times daily decreasing to once daily over four weeks.
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be willing and able to provide written informed consent. * Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study. * Be male or female of any race at least 18 years of age. * Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.
Exclusion criteria
* Contraindication to use of corticosteroids. * Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator. * Laser or any other intraocular surgery within the past three months. * Require use of ocular NSAID or systemic steroids. * Have known allergy or sensitivity to the study medications or their components * Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement. * Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. * Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation). * Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Flare at Resolution | 2 months |
Countries
United States
Participant flow
Recruitment details
Recruitment period Feb 2005 - Jun 2008 Subjects were recruited from surgical schedule.
Pre-assignment details
One subject was disqualified due to previous laser treatment. One subject did not receive study medication therefore was discontinued from study participation.
Participants by arm
| Arm | Count |
|---|---|
| Pred Forte Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Pred Forte: Four drops daily decreasing to once daily over four weeks. | 18 |
| EconoPred Plus EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks. | 21 |
| Prednisolone Acetate Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks. | 12 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Pred Forte | EconoPred Plus | Prednisolone Acetate | Total |
|---|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 15.2 | 68.3 years STANDARD_DEVIATION 13 | 65.7 years STANDARD_DEVIATION 16.6 | 66.5 years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 21 | 0 / 12 |
| serious Total, serious adverse events | 0 / 18 | 0 / 21 | 0 / 12 |
Outcome results
Primary
Percent Change in Flare at Resolution
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pred Forte 1% | Percent Change in Flare at Resolution | 64.8 Percent change in flare | Standard Deviation 15.2 |
| Econo Pred Plus 1% | Percent Change in Flare at Resolution | 68.3 Percent change in flare | Standard Deviation 13 |
| Predisolone Acetate 1% | Percent Change in Flare at Resolution | 65.7 Percent change in flare | Standard Deviation 16.6 |