A Feasibility, Double Blind, Randomized, Crossover Study to Evaluate the Tolerability of Oph1 0.5% Cyclosporine Ophthalmic Formulation Compared to Restasis in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- OphRx Ltd.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Drop Discomfort VAS score
研究概览
简要总结
20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.
详细描述
20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded, participant and Outcome Assessors are blinded to the intervention
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 20-50 years, inclusive.
- •Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- •Best-corrected visual acuity (BCVA) 20/40 or better in both eyes.
- •Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes.
- •Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes.
- •IOP (< 22mmHg), in both eyes.
- •No pathology findings in Slit-lamp biomicroscopy in both eyes.
- •Ability to comply with the requirements of the study and complete the questionnaire and a full sequence of protocol-related evaluations.
- •Ability to understand and provide written informed consent.
- •In the judgement of the investigator, the participant can safely perform study activity.
排除标准
- •Have chronic systemic disease of any form known.
- •In the case of women: be pregnant, breastfeeding or planning to become pregnant within the study period or women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- •Be a user of topical ophthalmic products of any kind.
- •Being a chronic drug user.
- •Be a user of contact lenses.
- •Have a history of any type of eye surgery.
- •Participating in clinical research studies 90 days prior to inclusion in the present study.
- •In the judgement of the investigator, any condition that could interfere with the intent of the study or would make participation not in the best interest of the participant.
研究组 & 干预措施
Arm I
Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation
干预措施: Oph1 (Drug)
Arm I
Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation
干预措施: Restasis (Drug)
Arm II
Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation
干预措施: Oph1 (Drug)
Arm II
Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation
干预措施: Restasis (Drug)
结局指标
主要结局
Drop Discomfort VAS score
时间窗: up to Fifth day per treatment (last dose for each treatment)
Eye Discomfort VAS scale from 0-100
次要结局
- Drop Comfort VAS score(1-minute post-Dose. Fifth day per treatment (last dose for each treatment))
- Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.(5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM)