Not yet recruiting NCT07600645
Contact Lens Trial Fitting Experience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lens A ( stenfilcon A ).
- Who it may be relevant to
- Registry conditions: Presbyopia. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of a Novel Multifocal Contact Lens Trial Fitting Experience
Overview
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
- Device Lens A ( stenfilcon A )
15 minutes of daily wear
Primary outcome measures
- Participant Lens Fitting Experience [Time frame: At the End of 15 minutes of daily wear]
Eligibility criteria
Inclusion criteria
- They are at least 40 years of age.
- They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
- 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).
- They have a minimum reading add of +0.75DS (based on their manifest refraction) and no more than +2.50DS.
- They have spherical equivalent refractive error between +4.50 to -11.00DS (some restrictions apply based on near add availability)
- They have refractive astigmatism of no greater than 0.75DC in each eye.
- They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye with manifest refraction.
- 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
- Is participating in any concurrent clinical or research trial.
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have a systemic disorder which would normally contraindicate contact lens wear.
- They are pseudophakic or aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Bellaire Family Eye Care — Bellaire
- Drs. Mcintyre Garza Avila & Jurica — Corpus Christi
Identifiers
NCT: NCT07600645 · CV-26-18