NCT06121531已完成不适用
A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- The effectiveness of corrected visual acuity
研究概览
简要总结
This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years old and above.
- •Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
- •Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
- •With +6.00D ~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
- •Have worn soft contact lens for at least 1 month prior to the study.
- •Willing to comply with the required wearing time and use specified contact lens care product.
- •Agree to comply with all study procedures and signed the informed consent form before enrollment.
排除标准
- •Anterior chamber infection, inflammation, or abnormality.
- •Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
- •Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
- •History of herpes simplex keratitis.
- •History of refractive surgery, keratoconus, or irregular cornea.
- •Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5 from page 38 to 43).
- •A pathologically dry eye syndrome (Schirmer test < 5 mm).
- •Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
- •Currently pregnant or lactation.
- •Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).
- •Have experienced discomfort when wearing hydrogel contact lens.
- •Subjects who are judged unsuitable for the study by the investigators.
结局指标
主要结局
The effectiveness of corrected visual acuity
时间窗: 3 Months
The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.
次要结局
- Change in diopter (Spherical and cylindrical power of subjective optometry)(1 week, 1 month, 2 months and 3 months)
- Average contact lens corrected visual acuity(1 week, 1 month, 2 months and 3 months)
- Lens fitting (lens centration, lens movement, coverage, and tightness)(1 week, 1 month, 2 months and 3 months)
- Effectiveness of corrected visual acuity(1 week, 1 month and 2 months)
- Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)(1 week, 1 month, 2 months and 3 months)
- Lens broken rate(1 week, 1 month, 2 months and 3 months)
- Lens state (lens front surface wettability, front surface deposits, back surface deposits)(1 week, 1 month, 2 months and 3 months)
- Subjective acceptance (comfort, vision, lens handling, lens cleaning)(1 week, 1 month, 2 months and 3 months)
研究者
研究点 (4)
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