A Prospective, Multi-center, Open-Label, Randomized Controlled, Non-Inferiority Clinical Study Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- Percentage of subjects with the best corrected distance visual acuity in both eyes with lenses ≥5.0 at the 1-month follow-up after using the contact lens lubricant.
研究概览
简要总结
This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.
Meanwhile, following statistical requirements, 152 rigid contact lens wearers are planned to be enrolled after screening and meeting the inclusion criteria. Participants will be randomly assigned to groups and provided with lenses, lubricants, and care solutions accordingly. Clinical follow-up assessments are scheduled at 1 week, 1 month, and 3 months after use.
The primary efficacy indexes are the percentage of patients with binocular comfort score ≥ Level 3 at the 1-month follow-up and the percentage of patients with best corrected distance visual acuity with contact lenses for both eyes ≥5.0 at the 1-month follow-up after using the contact lens lubricant. Secondary efficacy indexes include, best corrected distance visual acuity with lenses, visual acuity with lenses, residual diopter, tear break-up time, uncorrected visual acuity, examination of contact lens fitting status, lens assessment, and contact lens lubricant evaluation during the corresponding follow-up periods. Safety indexes include slit lamp examination, fundus examination, IOP, corneal endothelial cell, adverse events, serious adverse events, device defects that may lead to serious adverse events, other device defects during the corresponding follow-up periods.
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
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8 and older, no gender limitation;
- •Rigid gas permeable corneal contact lens (OK lens) wearers;
- •The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
- •Be able and willing to comply with all treatments and follow-ups;
- •Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself/herself or his/her legal guardian.
排除标准
- •Patients with only one eye meeting the inclusion criteria.
- •Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.
- •Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.
- •Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
- •Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;
- •Patients with a history of intraocular operation;
- •Patients with abnormal IOP (the single eye IOP <10 mmHg or >21mmHg, or the IOP difference of both eyes >5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination abnormalities.
- •Patients with dry eye syndrome or with break up time (BUT) <5s.
- •Subjects who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;
- •Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;
- •Patients who are pregnant, nursing or planning to conceive at the enrollment;
- •Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;
- •Other conditions for which the investigator judged the patient unsuitable for inclusion.
结局指标
主要结局
Percentage of subjects with the best corrected distance visual acuity in both eyes with lenses ≥5.0 at the 1-month follow-up after using the contact lens lubricant.
时间窗: 1 month
Percentage of subjects with comfort scores ≥ Level 3 for both eyes at the 1-month follow-up after using the contact lens lubricant.
时间窗: 1 month
次要结局
- Changes in subjective symptoms assessed by subjective acceptability Scale of National Medical Products Administration（NMPA）(1 week, 1 month, and 3 months)
- Changes in best corrected distance visual acuity with lenses(1 week, and 3 months)
- Changes in lens wearing vision and residual diopter(1 week, 1 month, and 3 months)
- Changes in tear break up time (TBUT)(1 week, 1 month, and 3 months)
- Changes in uncorrected visual acuity(1 week, 1 month, and 3 months)
- Changes in contact lens fitness examination(1 week, 1 month, and 3 months)
- Changes in lens assessment(1 week, 1 month, and 3 months)
- Changes in contact lens lubricant evaluation(1 week, 1 month, and 3 months)
- Changes in slit-lamp examinations(1 week, 1 month, and 3 months)
- Changes in fundus examinations(1 month and 3 months)
- Comparison between groups for intraocular pressure (IOP) at each follow-up visit, along with changes relative to baseline(1 week, 1 month, and 3 months)
- Comparison between groups for examination of corneal endothelial cell at each follow-up visit, along with changes relative to baselineChanges(3 months)
- Incidence of adverse events(From the date of randomization until the occurrence of adverse events, assessed for up to 3 months)
- Incidence of serious adverse event(From the date of randomization until the occurrence of serious adverse event, assessed for up to 3 months)