NCT03693183撤回2 期
A Double-Masked, Randomized, Single-Center Study Evaluating the Effect of 0.30% Ketorolac/0.80% HPMC, 0.80% HPMC and Vehicle on Symptoms of Dry Eye After Exposure to the Controlled Adverse Environment (CAE)
ORA, Inc.1 个研究点 分布在 1 个国家开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
研究概览
简要总结
The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.
详细描述
This is a double masked, randomized study with approximately 45 subjects randomized to one of the three treatment arms at a single site. There are 5 visits over the course of 16 days.
Visit 1: Day -7 Visit 2: Day 0 Visit 3: Day 2 Visit 4: Day 7 Visit 5: Day 9
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
- Triple (Participant, Care Provider, 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
- •Provide written informed consent;
- •Are 18 years of age or older;
- •Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- •Have a corrected visual acuity LogMar +0.7 (ETDRS) or better in each eye;
- •Have a reported history of dry eye in each eye;
- •Have a history of use of or a desire to use an eye drop for dry eye symptoms within the past 6 months;
- •Have a central corneal sensitivity score greater than 55 mm in each eye at Visit 1;
- •Have an average diary reported score for ocular discomfort, burning, dryness, grittiness, or stinging of ≥ 1.5 during the one week run-in period between Visits 1 and 2;
- •Have a greater than or equal to 1 fluorescein staining score in any region in at least one eye prior to exposure to the CAE at Visit 1;
- •Report greater than or equal 3 in worst symptom for all diary entries between visits 2 and 3
- •If female and of childbearing potential. Are not pregnant, nursing, or planning a pregnancy. Women of childbearing potential are required to have a negative urine pregnancy test at the screening and exit visits and agree to use an acceptable method of contraception for the duration of the study.
排除标准
- •Have contraindications to the use of the study medication(s);
- •Have a known allergy or sensitivity to the study medication(s) or their components;
- •Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- •Are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis);
- •Wear contact lenses within 1 week of Visit 1 or throughout the duration of the study;
- •Have previously had laser in situ keratomileusis (LASIK) surgery;
- •Are currently taking any topical ophthalmic prescriptions or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and cannot discontinue these medications 2 hours prior to Visit 1 and for the duration of the trial;
- •Have used Restasis® within 30 days of Visit 1;
- •Have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance;
- •Are currently taking (at Visit 1) any medication known to cause ocular drying that has not been used on a stable dosing regimen for 30 days prior to Visit 1;
- •Are currently pregnant, nursing, or planning a pregnancy;
- •(For women of childbearing potential) Are unwilling to submit a urine sample for a pregnancy test at Visit 1 and at exit visit;
- •Have received another experimental drug or device within 30 days of Visit 1.
研究组 & 干预措施
Ketorolac/HPMC
Experimental
Drug: Ketorolac/HPMC Ophthalmic Solution
1 drop administered in each eye 4 times per day for 2 days
干预措施: Ketorolac/HPMC (Drug)
HPMC
Active Comparator
Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution
1 Drop administered in each eye 4 times per day for 2 days
干预措施: HPMC (Drug)
Vehicle
Placebo Comparator
Drug: Vehicle Ophthalmic Solution
1 drop administered in each eye 4 times a day for 2 days
干预措施: Vehicle (Drug)
结局指标
主要结局
Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
时间窗: Day 0 through Day 9
Evaluate the symptoms of Ketorolac and HPMC on ocular discomfort in subjects with dry eye syndrome.
次要结局
- Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.(Day 0 through Day 9)
研究者
研究点 (1)
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