DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Preference
研究概览
简要总结
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.
详细描述
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.
Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Any adult patient who is planned to undergo bilateral LASIK surgery.
- •Refractive error between the 2 eyes of 2 Diopters or less
- •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
- •Patients who choose to have monovision after LASIK
- •Patients with corneal pathology that may interfere with LASIK outcomes
- •Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- •Active infectious ocular or systemic disease.
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- •Patients with known hypersensitivity to Dexamethasone.
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
- •Patients with a history of ocular inflammation or macular edema.
- •Patients with allergy or inability to receive topical antibiotic.
- •Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
- •Patients with a corticosteroid implant (i.e. Ozurdex).
- •Active or history of chronic or recurrent inflammatory eye disease in either eye
- •Ocular pain in either eye
- •Proliferative diabetic retinopathy in either eye
- •Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
- •Laser or incisional ocular surgery during the study period and 6 months prior in either eye
- •History of cauterization of the punctum
研究组 & 干预措施
Group A
Dextenza
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group B
Topical Prednisolone
干预措施: Topical Prednisolone (Drug)
结局指标
主要结局
Patient Preference
时间窗: Through Month 1 (Day 28 +/- 3 days)
As measured by COMTOL adapted survey.
Patient Comfort
时间窗: Through Month 1 (Day 28 +/- 3 days)
As measured by SPEED Questionnaire.
次要结局
- Ocular Surface Health(Through Month 1 (Day 28 +/- 3 days))
- Visual Outcomes(Through Month 1 (Day 28 +/- 3 days))
- Ocular Pain(Through Month 1 (Day 28 +/- 3 days))