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Not yet recruiting NCT07600645

Contact Lens Trial Fitting Experience

No phase Interventional Presbyopia

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗