Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mean change in pain score
研究概览
简要总结
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
详细描述
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate 1% for the treatment of pain, and inflammation following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
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
- None
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
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •Age 18 years and older
- •Scheduled corneal transplant surgery: PKP, DSEK, DMEK
- •Willing and able to comply with clinic visits and study related procedures
- •Willing and able to sign the informed consent form
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Patients under the age of
- •Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- •Active infectious systemic disease
- •Active infectious ocular or extraocular disease
- •Presence of punctal plug in the study eye
- •Obstructed nasolacrimal duct in the study eye(s)
- •Hypersensitivity to dexamethasone or prednisolone eye drops
- •Patients being treated with immunomodulating agents in the study eye(s)
- •Patients being treated with immunosuppressants and/or oral steroids
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
PKP with Dextenza (study)
Patients undergoing PKP will receive Dextenza insert with:
topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
PKP with Dextenza (study)
Patients undergoing PKP will receive Dextenza insert with:
topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
PKP without Dextenza (Controlled)
Patients undergoing PKP will receive:
topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
DSEK with Dextenza (study)
Patients undergoing DSEK will receive Dextenza insert with:
topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
DSEK with Dextenza (study)
Patients undergoing DSEK will receive Dextenza insert with:
topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
DSEK without Dextenza (Controlled)
Patients undergoing DSEK will receive:
topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
DMEK with Dextenza (study)
will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
DMEK with Dextenza (study)
will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
DMEK without Dextenza (Controlled)
Patients undergoing DMEK will receive:
topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.
PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
结局指标
主要结局
Mean change in pain score
时间窗: Assessed on Day 1,7 and 30
as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible
Mean change in inflammation (Cell and Flare) scores
时间窗: Assessed on Day 1,7 and 30
as measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1
次要结局
- Mean change in duration to corneal re-epithelization(Assessed on Day 1 and 7)
- Mean change in size of epithelial defect(Assessed on Day 1 and 7)
- Impact on the practice/medical team of decreasing the drop burden(Assessed on day 30)
- Mean change in duration to clearing of corneal edema(Assessed on Day 30, 60 and 90)
研究者
Nicole Fram M.D.
Principal Investigator
Advanced Vision Care