N/A Not Applicable
Conditions
Interventions
This was a feasibility study to evaluate the retention time of a polymer on the eye in order to provide insights into new product development programs. Each commercial eyedrop was used by all subject
Sponsors
CooperVision Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years of age 2. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear) 3. Spherical spectacle prescription between +6.00 and -10.00D (inclusive) 4. Correctable to 6/12 (20/40) or better in each eye 5. Require visual correction in both eyes (monovision allowed but no monofit) 6. Have normal eyes with no evidence of any ocular abnormality or disease.
Exclusion criteria
Exclusion criteria: 1. Previously shown sensitivity to any of the study solutions’ components. 2. Any systemic or ocular disease or allergies affecting ocular health. 3. Using systemic or topical medications that will, in the investigator’s opinion, affect ocular physiology or lens performance. 4. Clinically significant (>Grade 3) corneal stromal edema, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. 5. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea. 6. Keratoconus or other corneal irregularity. 7. Aphakia or amblyopia. 8. Has diabetes. 9. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). 10. History of chronic eye disease (e.g. glaucoma or ARMD). 11. Pregnant or lactating or planning a pregnancy at the time of enrolment. 12. Participation in any concurrent clinical trial or in last 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured on each study day: 1. Monocular comfort [1-100, in 1 unit steps] will be measured using a Visual Analog Scale. 2. Pre-lens Non-invasive break-up time (NIBUT) [s] will be measured using a Keeler Tearscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured on each study day: 1. Subjective dryness [1-100, in 1 unit steps] will be measured using a Visual Analog Scale. 2. Subjective vision quality [1-100, in 1 unit steps] will be measured using a Visual Analog Scale. 3. Lens preference for comfort [R/L, Likert 1-5] will be measured using a Likert Scale. 4. Ocular health (limbal hyperaemia and corneal staining) will be measured using a slit lamp microscope. | — |
Countries
United Kingdom
Outcome results
None listed