The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Ocular Redness
研究概览
简要总结
This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are of legal age and capacity to volunteer.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They agree not to participate in other clinical research for the duration of this study.
- •They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)
- •They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.
- •At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- •They currently use silicone hydrogel soft contact lenses.
- •They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They have had cataract surgery.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or lactating.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
研究组 & 干预措施
Synergi / comfilcon A
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
干预措施: comfilcon A (Device)
Synergi / comfilcon A
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
干预措施: Synergi (Device)
Synergi / comfilcon A
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
干预措施: stenfilcon A (Other)
Biotrue / comfilcon A
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
干预措施: comfilcon A (Device)
Biotrue / comfilcon A
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
干预措施: Biotrue (Device)
Biotrue / comfilcon A
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
干预措施: stenfilcon A (Other)
结局指标
主要结局
Ocular Redness
时间窗: 1 week, 2 weeks, 4 weeks
Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
Ease of Lens Insertion
时间窗: 1 week, 2 weeks, 4 weeks
Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
Conjunctival Hyperaemia
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Limbal Hyperaemia
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Corneal Staining
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
Papillary Conjunctivitis
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Comfort
时间窗: 4 weeks
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Vision
时间窗: 4 weeks
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Dryness
时间窗: 1 week, 2 weeks, 4 weeks
Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
Burning/Stinging
时间窗: 1 week, 2 weeks, 4 weeks
Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
Ease of Lens Removal
时间窗: 1 week, 2 weeks, 4 weeks
Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
Ease of Use of Solution
时间窗: 1 week, 2 weeks, 4 weeks
Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
Overall Score
时间窗: 1 week, 2 weeks, 4 weeks
Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.
Comfort
时间窗: 1 week
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Comfort
时间窗: 2 weeks
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Vision
时间窗: 1 week
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Vision
时间窗: 2 weeks
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
次要结局
未报告次要终点