NCT00654550已完成1 期
A Phase 1 Randomized, Prospective, Double-Masked, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Subjects Following Bilateral Photorefractive Keratectomy (PRK) for the Correction of Mild to Moderate Myopia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following bilateral PRK for the correction of mild to moderate myopia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female pre-presbyopic myopes.
- •Aged between 20 and 50 years inclusive.
- •Females are eligible to participate only if they are currently non-pregnant and non-lactating. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control.
- •Subjects willing and able to undergo bilateral PRK for the correction of their myopia.
- •Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.
- •No more than 1.0 D of refractive difference between eyes.
- •Stable prescription in both eyes as defined by <0.25 D change over the preceding 2 years.
- •Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period.
- •Subjects who are willing and able to give written informed consent to take part in the study.
排除标准
- •Subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study.
- •Subjects who have previously had corneal surgery.
- •Subjects who require Mitomycin C following their PRK.
- •Subjects with any ocular disease or corneal abnormality, including but not limited to:
- •Decreased corneal sensation / neurotrophic cornea;
- •Corneal vascularization;
- •Keratoconus;
- •Keratoconjunctivitis sicca requiring chronic treatment;
- •Lagophthalmos;
- •Blepharitis;
- •History of infectious keratitis;
- •History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
- •Significant dry eye disease that requires regular topical treatment;
- •Corneal thickness <480 µm at the thinnest point, and
- •Posterior elevation >40 mmHg.
- •Subjects with corneal haze >+1 as assessed using the grading scale in the protocol.
- •Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
- •Subjects with:
- •Diabetes;
- •Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid arthritis;
- •Severe atopic disease;
- •Any systemic disease or condition where the subject is immunocompromized.
- •Subjects who require any systemic medication that affects healing, e.g., steroids, hormone replacement therapy.
- •Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
- •Subjects who have participated in a clinical trial within the 30 days prior to the date on which PRK is scheduled.
研究组 & 干预措施
1
Experimental
干预措施: Nexagon™ or Nexagon™ vehicle (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 30 days post-application
次要结局
- To evaluate the clinical effect of Nexagon™(30 days post-application)
研究者
研究点 (1)
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