NCT02804191已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ocuwize LTD
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- The change from baseline in lissamine green conjunctival staining (LGCS) score.
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
详细描述
Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.
This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female of any race and ≥ 18 years of age.
- •Willing and able to provide voluntary written informed consent.
- •Moderate to severe conjunctivochalasis defined by:
- •LIPCOF score ≥ 2; and
- •Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
- •Willing and able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
- •Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
- •A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
- •Subjects with pterygium.
- •Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
- •Subjects with blepharitis requiring treatment.
- •Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
- •Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
- •Subjects who have used any of the following medications or treatments:
- •LASIK or PRK surgery within 12 months of Visit
- •Use of contact lenses within 7 days of Visit
- •Punctal plug insertion within 30 days of Visit
- •Use of topical or systemic cyclosporine within 30 days of Visit
- •Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit
- •Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
- •Active abuse of alcohol or drugs.
- •Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
- •Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study
研究组 & 干预措施
LO2A
Experimental
Sodium Hyaluronate
干预措施: LO2A (Drug)
Placebo-Controlled
Placebo Comparator
Saline.
干预措施: Saline (Drug)
结局指标
主要结局
The change from baseline in lissamine green conjunctival staining (LGCS) score.
时间窗: 3 Months
次要结局
- The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline(3 Months)
- The change from baseline in LGCS score(1 month)
- The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months(3 Months)
- The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months(3 Months)
研究者
研究点 (3)
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