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Completed

NCT Number: NCT03496701

Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eric White, O.D., Inc., San Diego, California, United States

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About this study

This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 35 years of age (inclusive)
  • Has read and signed the informed consent letter
  • Is willing and anticipated to follow instructions and maintain the appointment schedule
  • Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
  • Habitually wears or is able to be adequately refit into MyDay Sphere lenses
  • Demonstrates an acceptable fit with the study lenses
  • Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
  • Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
  • Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
  • Has clear corneas and no active ocular disease
  • Has a contact lens refraction that fits within the available parameters of the study lenses.

Exclusion criteria

A person will be excluded from the study if he/she:

  • Is participating in any concurrent clinical research study
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a systemic condition that, in the opinion of the investigator, may affect the study measures
  • Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
  • Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone refractive surgery.
  • Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
  • Has participated in any other type of eye related clinical or research study within the last 7 days
  • Is habitually using rewetting/ lubricating eye drops (more than once per day)

Treatment and study plan

Test lens

Device

contact lens

Other names: stenfilcon A Test lens

Control lens

Device

contact lens

Other names: stenfilcon A Control lens

Primary outcomes

  1. Overall Lens Fit Acceptance

    Time frame: Baseline (After 10 minutes of lens dispense)

    Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

  2. Overall Lens Fit Acceptance

    Time frame: 1 week on each study lenses

    Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

Secondary outcomes

  1. Lens Centration

    Time frame: Baseline - After 10 minutes of lens dispense

    Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

  2. Lens Centration

    Time frame: 1 week on each study lenses

    Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

  3. Post-blink Movement

    Time frame: Baseline (after 10 minutes of lens dispense)

    Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

  4. Post-blink Movement

    Time frame: 1 week on each study lenses

    Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 12, 2018
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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