NCT00345046已完成4 期
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent Change in Flare at Resolution
研究概览
简要总结
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Pred Forte 1%
Active Comparator
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
干预措施: Pred Forte (Drug)
EconoPred Plus 1%
Active Comparator
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
干预措施: EconoPred Plus (Drug)
Prednisolone Acetate 1%
Active Comparator
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
干预措施: Prednisolone Acetate (Drug)
结局指标
主要结局
Percent Change in Flare at Resolution
时间窗: 2 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Comparison the effect of topical prednisolone acetate and fluorometholone for photorefractive keratectomy management a randomized double masked clinical studyrefractive errorrefractive surgeryphotorefractive keratectomycorticosteroidprednisolone acetatefluorometholonepainTCTR20190824003Srinakarind hospital25
尚未招募
不适用
A study to assess the response to two different doses of prednisolone in children with relapse of nephrotic syndrome.CTRI/2018/05/014075Chacha Nehru Bal Chikitsalaya
已完成
2 期
Comparison of therapeutic effects of prednisolone, acyclovir, and combination of these drugs in Bell´s PalsyBell's palsy.Facial palsyIRCT201109187575N1Arak University of Medical Sciences,Vice chancellor for research180
已完成
2 期
A comparison of efficacy of oral prednisolone plus tacrolimus and azathioprine in the treatment of pemphigus vulgarisIRCT2012073010450N1Shiraz University of Medical Sciences46
招募中
2 期
comparison effects of two regimens: prednisolone plus cimetidine versus prednisolone plus colchicine in control of frequency and duration of fever episodes In the Periodic fever, Aphthous stomatitis, Pharyngitis and Adenitis in children referred to pediatric medical centerPFAPA syndrome.IRCT20191222045847N1Tehran University of Medical Sciences80