ISRCTN17082971已完成未知
An investigation of the ocular inflammatory response for two soft contact lens solutions
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
2020 results in https://pubmed.ncbi.nlm.nih.gov/31725697/ (added 21/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Legal age (18) and capacity to volunteer.
- •2. Understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •3. Willing and able to follow the protocol.
- •4. Agree not to participate in other clinical research for the duration of this study.
- •5. Current soft contact lens wearers, i.e. they have worn soft contact lenses within the past six months.
- •6. Can be satisfactorily fitted with the study lens types.
- •7. Willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
- •8. Understand the use of the care solutions and willing to comply with the instruction given in this study.
- •9. Own a wearable pair of spectacles which, in the opinion of the investigator, provide adequate vision in each eye.
排除标准
- •1. Ocular disorder which would normally contra-indicate contact lens wear or the care solutions used in the study.
- •2. Systemic disorder which would normally contra-indicate contact lens wear or the care solutions used in the study.
- •3. Topical medication such as eye drops or ointment.
- •4. Cataract surgery.
- •5. Corneal refractive surgery.
- •6. Corneal distortion or have keratoconus.
- •7. Pregnant or lactating.
- •8. Currently on immunosuppressive medication.
- •9. Ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •10. 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.
- •11. Taken part in any other contact lens or care solution clinical trial or research within two weeks prior to starting this study.
研究者
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