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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Test lens; Device: control lens

• Registration Number: NCT03496701
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-04-18
• Primary Completion: 2018-06-01
• Study Completion: 2019-01-17
• Disposition First Submitted: 2019-07-30
• Disposition First Submitted QC: 2019-08-12
• Disposition First Posted: 2019-09-11
• Status Verified: 2021-06
• Results First Submitted: 2021-06-08
• Results First Submitted QC: 2021-06-08
• Last Update Submitted: 2021-06-28
• Results First Posted: 2021-06-29
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stenfilcon A / Test lens	control lens	All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.
Stenfilcon A / Test lens	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.

Primary Outcome Measures

Name	Time	Method
Overall Lens Fit Acceptance	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 Outcome Measures

Name	Time	Method
Lens Centration	1 week on each study lenses	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Post-blink Movement	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)

Trial Locations

Locations (4)

Nittany Eye Associates; 🇺🇸 State College, Pennsylvania, United States

Golden Optometric Group; 🇺🇸 Whittier, California, United States

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

Golden Vision; 🇺🇸 Sarasota, Florida, United States