ISRCTN28788224已完成未知
Three-month clinical evaluation of DP037, a multipurpose solution for Rigid Gas Permeable (RGP) lenses
Menicon Co. Ltd (Japan)0 个研究点目标入组 60 人开始时间: 2012年7月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Be a currently adapted RGP contact lens wearer (>3 months of lens wear)
- •2. Wearing their habitual RGP contact lenses to baseline visit
- •3. Be at least 18 years of age
- •4. Have corneal astigmatism less than or equal to 3.00D
- •5. Have clear corneas and be free of any anterior segment disorders
- •6. Be correctable through spherocylindrical refraction to 6/12 (20/40) or better in each eye
- •7. Spherical spectacle prescriptions between +6.00D and -10.00D (inclusive)
- •8. Require visual correction in both eyes (monovision allowed, but not monofit)
- •9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •9.1. No amblyopia
- •9.2. No strabismus
- •9.3. No evidence of lid abnormality or infection
- •9.4. No conjunctival abnormality or infection that would contraindicate contact lens wear
- •9.5. No clinically significant slit lamp findings (i.e. corneal staining, stromal oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities)
- •9.6. No other active ocular disease; 1. Be a currently adapted RGP contact lens wearer (>3 months of lens wear)
- •2. Wearing their habitual RGP contact lenses to baseline visit
- •3. Be at least 18 years of age
- •4. Have corneal astigmatism less than or equal to 3.00D
- •5. Have clear corneas and be free of any anterior segment disorders
- •6. Be correctable through spherocylindrical refraction to 6/12 (20/40) or better in each eye
- •7. Spherical spectacle prescriptions between +6.00D and -10.00D (inclusive)
- •8. Require visual correction in both eyes (monovision allowed, but not monofit)
- •9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •9.1. No amblyopia
- •9.2. No strabismus
- •9.3. No evidence of lid abnormality or infection
- •9.4. No conjunctival abnormality or infection that would contraindicate contact lens wear
- •9.5. No clinically significant slit lamp findings (i.e. corneal staining, stromal oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities)
- •9.6. No other active ocular disease
排除标准
- •1. Under 18 years of age
- •2. Wear toric or multifocal RGP designs
- •3. Previously shown a sensitivity to any of the study solutions components
- •4. Any systemic or ocular disease or allergies affecting ocular health
- •5. Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance
- •6. Clinically significant (no less than Grade 3) corneal staining, corneal stromal oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear
- •7. Any corneal infiltrates or any corneal scarring or neovascularisation within the central 5mm of the cornea
- •8. Keratoconus or other corneal irregularity
- •9. Aphakia or amblyopia
- •10. Subjects who have undergone corneal refractive surgery or any anterior segment surgery
- •11. Abnormal lacrimal secretions
- •12. Has diabetes
- •13. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g. Human immunodeficiency virus (HIV)]
- •14. History of chronic eye disease [e.g. glaucoma or Age-related macular degeneration (ARMD)]
- •15. Pregnant or lactating or planning a pregnancy at the time of enrolment
- •16. Participation in any concurrent clinical trial or in last 30 days; 1. Under 18 years of age
- •2. Wear toric or multifocal RGP designs
- •3. Previously shown a sensitivity to any of the study solutions components
- •4. Any systemic or ocular disease or allergies affecting ocular health
- •5. Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance
- •6. Clinically significant (no less than Grade 3) corneal staining, corneal stromal oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear
- •7. Any corneal infiltrates or any corneal scarring or neovascularisation within the central 5mm of the cornea
- •8. Keratoconus or other corneal irregularity
- •9. Aphakia or amblyopia
- •10. Subjects who have undergone corneal refractive surgery or any anterior segment surgery
- •11. Abnormal lacrimal secretions
- •12. Has diabetes
- •13. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g. Human immunodeficiency virus (HIV)]
- •14. History of chronic eye disease [e.g. glaucoma or Age-related macular degeneration (ARMD)]
- •15. Pregnant or lactating or planning a pregnancy at the time of enrolment
- •16. Participation in any concurrent clinical trial or in last 30 days
研究者
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