Myopia
Conditions
Keywords
Contact lens, The Young Theory
Brief summary
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.
Detailed description
This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).
Interventions
DEVICEFirst pair Senofilcon A contact lens
Fit assessment of the first pair contact lenses.
DEVICESecond pair Senofilcon A contact lens
Fit assessment of the second pair of contact lenses.
DEVICEThird pair Senofilcon A contact lens
Fit assessment of the third pair of contact lenses.
Sponsors
Visioncare Research Ltd.
Graeme Young
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be masked to lens type and lens codes. A sealed decoding envelope will be provided to the investigator. In the event of an emergency the investigator will break the masking and the medical monitor will be notified.
Intervention model description
Each subject will wear the three contact lens types bilaterally in random succession
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-70 years. * Able to read, comprehend and sign an informed consent. * Willing to comply with the wear and study assessment schedule. * Spherical distance prescription between -0.50 and -6.00 (inc.). * Astigmatism, if present,≤1.50DC in both eyes. * Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).
Exclusion criteria
* Previous anterior ocular surgery * Any active corneal infection, injury or inflammation . •Large pinguecula likely to affect soft lens fit * Systemic or ocular disease or medication which might interfere with CL wear * Pregnancy or breastfeeding * Participation in any concurrent trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens fit (position on the eye) in mm | 25 minutes | Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm), |
| Lens edge tightness fit grade 0-4 | 5 minutes | Edge tightness (grade 0-4) |
| Lens tightness fit graded as % | 5 minutes | Tightness (push-up %), |
| Lens overall fit grade 0-5 | 5 minutes | Overall fit acceptability (Grade 0-5), |
Countries
United Kingdom
Outcome results
None listed