Contact lens discomfort Eye Diseases
Conditions
Interventions
Symptomatic contact lens wearers will attend a screening, baseline visit then lens fit and follow-up visits for each 2 week part and there will be a minimum of 3 days between parts. In each part the s
Sponsors
CooperVision, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be defined as symptomatic contact lens wearers if they present with at least one of the following two criteria at baseline: 1. Difference in reported wearing time and comfortable wearing time >2 hours 2. Score =14 by CLDEQ-8 All subjects must satisfy the following conditions prior to enrolling in the study: 1. Be =18 years of age 2. Able to read, comprehend and sign an informed consent 3. Willing to comply with the wear and study assessment schedule 4. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear) 5. Spherical spectacle prescription between +6.00 and -10.00D (inclusive) 6. Correctable to 6/12 (20/40) or better in each eye 7. Require visual correction in both eyes (monovision and multifocal allowed but no monofit) 8. 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: 8.1. Clear central corneas 8.2. No anterior segment disorder 8.3. No amblyopia 8.4. No strabismus 8.5. No evidence of lid abnormality or infection 8.6. No conjunctival abnormality or infection that would contraindicate contact lens wear 8.7. No clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation) 8.8. No other active ocular disease or recent surgery
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 oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, 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. 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 any clinical trial in the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and after 2 weeks for each cross-over phase: 1. Binocular subjective comfort measured using a visual analogue scale, 1-100, in 1 unit steps 2. Treatment preference for comfort (1st/2nd) measured using Likert scale, 1-5 3. Pre-lens non-invasive break-up time (NIBUT) measured using a tearscope in seconds | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and after 2 weeks for each cross-over phase: 1. Average and comfortable wearing time, measured using verbal report (Hrs Mins) 2. Subjective dryness measured using visual analogue scale, 1-100, in 1 unit steps 3. Subjective vision quality overall measured using visual analogue scale, 1-100, in 1 unit steps 4. Limbal and bulbar hyperaemia (graded 0-4) measured using slit lamp biomicroscopy 5. Corneal staining by quadrant for type (graded 0-4 scale); area (0-10) measured using slit lamp biomicroscopy | — |
Countries
United Kingdom
Outcome results
None listed