Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lens Centration
研究概览
简要总结
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
详细描述
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 and 40 years of age (inclusive).
- •Has had a self-reported visual exam in the last two years.
- •Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
- •Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- •Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
- •Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- •Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has read, understood and signed the information consent letter.
- •Patient contact lens refraction should fit within the available parameters of the study lenses.
- •Is willing to comply with the wear schedule.
- •Is willing to comply with the visit schedule.
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has a CL prescription outside the range of - 1.00 to - 6.00D
- •Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- •Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- •Presence of clinically significant (grade 2-4) anterior segment abnormalities.
- •Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula, or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from of the limbus
- •Giant papillary conjunctivitis (GCP) worse than grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, Seborrheic conjunctivitis
- •History of corneal ulcers or fungal infections
- •Poor personal hygiene
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Has aphakia, keratoconus or a highly irregular cornea.
- •Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
研究组 & 干预措施
Omafilcon A
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
干预措施: Omafilcon A (Device)
Somofilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
干预措施: Somofilcon A (Device)
Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
干预措施: Omafilcon A - Proclear (PC) (Device)
结局指标
主要结局
Lens Centration
时间窗: 1 Hour
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Bulbar Redness
时间窗: 1 Hour
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Visual Acuity
时间窗: Baseline (lens insertion), 1 hour
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Comfort
时间窗: Insertion, 1hr
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Post-blink Lens Movement
时间窗: 1 Hour
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Lens Fit Acceptance
时间窗: 1 Hour
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Preference
时间窗: 1 Hour
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Limbal Redness
时间窗: 1 Hour
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
次要结局
未报告次要终点