Nearsightedness and farsightedness. Eye Diseases Myopia and hyperopia
Conditions
Sponsors
Ocutec Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years old 2. Willing to wear supplied over-spectacle correction if required 3. Existing soft contact lens wearers (at least 4 weeks daily wear prior to study). 4. Require a visual correction in both eyes (monovision allowed but no monofit). 5. Have a spherical contact lens requirement in the range of -1.00D to -4.00D. 6. Have no greater than 1.00D difference in contact lens spherical requirement between eyes. 7. Have astigmatism <1.25D in both eyes. 8. Monocular distance visual acuity correctable to 6/9 (20/30) or better in each eye with sphero-cylindrical refraction. 9. 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: 9.1. Clear central corneas 9.2. No anterior segment disorder 9.3. No clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation) 9.4. No other active ocular disease or recent surgery
Exclusion criteria
Exclusion criteria: 1. Any systemic disease affecting ocular health 2. Any systemic or topical medications that will in the investigator’s opinion affect ocular physiology or contact lens performance 3. Severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses 4. Persistent, clinically significant corneal or conjunctival staining using fluorescein dye (= Grade 3) 5. Aphakic 6. Undergone corneal refractive surgery 7. Participating in any other type of eye related clinical or research study 8. Pregnancy, lactating or planning a pregnancy at the time of enrollment 9. Participation in any trial within the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comfort is assessed by the subject is assessed by the subject at 30 minutes and 8 hours 2. High contrast VA is measured using computer-generated logMAR charts at 30 minutes and 8 hours 3. Non-invasive break-up time is measured using the Keeler Tearscope® and grid at 30 minutes and 8 hours 4. Pre-lens tear film quality is measured by slit lamp examination at 30 minutes and 8 hours 5. Overall lens fit is measured by slit lamp examination after at 30 minutes and 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bulbar hyperaemia (0-4) is measured by Slit Lamp examination at 30 minutes and 8 hours or at another time if the subject is discontinued from the study early 2. Corneal staining (0-4) is measured by Slit Lamp examination at 8 hours or at another time if the subject is discontinued from the study early | — |
Countries
United Kingdom
Contacts
Public ContactMichelle Kerr
Outcome results
None listed