Presbyopia
Conditions
Brief summary
This study will assess a trial fitting experience with contact lenses.
Detailed description
This study is designed to evaluate a contact lens fitting experience utilizing an at home trial kit.
Interventions
DEVICELens A ( stenfilcon A )
15 minutes of daily wear
Sponsors
CooperVision International Limited (CVIL)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are at least 40 years of age. 2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent. 3. They habitually wear MyDay sphere or MyDay Energys contact lenses (including sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction). 4. They have a minimum reading add of +0.75DS (based on their manifest refraction) and no more than +2.50DS. 5. They have spherical equivalent refractive error between +4.50 to -11.00DS (some restrictions apply based on near add availability) 6. They have refractive astigmatism of no greater than 0.75DC in each eye. 7. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye with manifest refraction. 8. They report at least one near-vision difficult symptom consistent with presbyopia as evidenced by a response of 'slight difficult' or worse on ³ 1 item of the Near Activity Visual Questionnaire (NAVQ-P) at screening.
Exclusion criteria
1. Is participating in any concurrent clinical or research trial. 2. They have an ocular disorder which would normally contraindicate contact lens wear. 3. They have a systemic disorder which would normally contraindicate contact lens wear. 4. They are pseudophakic or aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. 8. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Lens Fitting Experience | At the End of 15 minutes of daily wear | Participant's readiness to finalize a multifocal contact lens prescription after using an at home trial kit based on a scale of 1- 5 (1 - Good and 5 - Bad). |
Countries
United States
Contacts
CONTACTKelly Voltz
Outcome results
None listed