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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Pair Senofilcon A contact lens | Active Comparator | The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal. |
|
| Second pair Senofilcon A contact lens | Active Comparator | The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal. |
|
| Third pair Senofilcon A contact lens | Active Comparator | The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First pair Senofilcon A contact lens | Device | Fit assessment of the first pair contact lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens fit (position on the eye) in mm | 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), | 25 minutes |
| Lens edge tightness fit grade 0-4 | Edge tightness (grade 0-4) | 5 minutes |
| Lens tightness fit graded as % | Tightness (push-up %), | 5 minutes |
| Lens overall fit grade 0-5 | Overall fit acceptability (Grade 0-5), | 5 minutes |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young, PhD MPhil | Managing director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visioncare research | Farnham | Surrey | GU9 7EN | United Kingdom | ||
| Aston University Optometry Clinic |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 25, 2017 | Dec 8, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2017 | Dec 8, 2017 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | Dec 18, 2017 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Each subject will wear the three contact lens types bilaterally in random succession
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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.
| Second pair Senofilcon A contact lens | Device | Fit assessment of the second pair of contact lenses. |
|
| Third pair Senofilcon A contact lens | Device | Fit assessment of the third pair of contact lenses. |
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| Birmingham |
| West Midlands |
| B4 7ET |
| United Kingdom |