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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test lens; Device: control lens

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric White, O.D., Inc.
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Florida
    • Sarasota, Florida, United States, 34232
      • Golden Vision
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stenfilcon A / Test lens; All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.	Device: Test lens; contact lens; Other Names: stenfilcon A Test lens; Device: control lens; contact lens; Other Names: stenfilcon A Control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Lens Fit Acceptance	Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)	Baseline (After 10 minutes of lens dispense)
Overall Lens Fit Acceptance	Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)	1 week on each study lenses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)	Baseline - After 10 minutes of lens dispense
Lens Centration	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)	1 week on each study lenses
Post-blink Movement	Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)	Baseline (after 10 minutes of lens dispense)
Post-blink Movement	Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)	1 week on each study lenses

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: David Ardaya, Golden Optometric Group, CA; Principal Investigator: Shane Kannarr, Kannarr Eye Care, KS; Principal Investigator: Michael Cymbor, Nittany Eye Associates, PA; Principal Investigator: Wayne Golden, Golden Vision, FL; Principal Investigator: Eric M. White, CA

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes