Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Ocular Surface Staining From Baseline
研究概览
简要总结
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.
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
- 是
入选标准
- •18 years of age or older
- •Signs and symptoms of Dry Eye Disease
- •Consent to treat with topical immunomodulator
- •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
- •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
- •Altered nasolacrimal flow of either acquired, induced, or congenital origin
- •Hypersensitivity to dexamethasone
- •Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
- •Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Restasis and Lotemax
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
干预措施: Loteprednol Etabonate (Drug)
Restasis and Lotemax
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
干预措施: Cyclosporine (Drug)
Restasis and Dextenza
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
干预措施: Cyclosporine (Drug)
Restasis and Dextenza
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
干预措施: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert (Drug)
Restasis
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Mean Ocular Surface Staining From Baseline
时间窗: Baseline to Week 4, Week 8 and Week 12
The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.
次要结局
- Tear Breakup Time (Seconds)(Baseline to Week 4, Week 8 and Week 12)
- Meibomian Gland Scores(Baseline to Week 4, Week 8 and Week 12)
- Mean Schirmer Tear Test 1 Score(Baseline to Week 4, Week 8 and Week 12)
- Tear Osmolarity(Baseline to Week 4, Week 8 and Week 12)
- Mean Conjunctival Staining(Baseline to Week 4, Week 8 and Week 12)
- DEQ-5 Score(Baseline to Week 4, Week 8 and Week 12)
研究者
Thomas Chester, OD
Principal Investigator
Cleveland Eye Clinic