Recruiting NCT07444658
Performance of Two Daily Disposable Multifocal Contact Lenses
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 (kalfilcon A), Lens B (stenfilcon A).
- Who it may be relevant to
- Registry conditions: Presbyopia. Basic parameters: from 18 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 →
Overview
This study will compare the performance of two daily disposable multifocal soft contact lenses.
Detailed description
This is a double-masked, randomized, crossover, 1-week, real world dispensing study, where participants will wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each.
Interventions
- Device Lens A (kalfilcon A)
Daily disposable, soft contact lenses worn for one week - Device Lens B (stenfilcon A)
Daily disposable, soft contact lenses worn for one week
Primary outcome measures
- Subjective Visual Acuity [Time frame: Through study completion, approximately 4 hours]
Eligibility criteria
Inclusion criteria
- They are at least 18 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 use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six months.
- They have a minimum reading add of +0.75DS (based on their spectacle refraction)
- They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and 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.
Exclusion criteria
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Berkeley — Berkeley
Identifiers
NCT: NCT07444658 · MKTG-26-01