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

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT03496701

Run by

CooperVision, Inc.

People needed

77

Starts

2018-04-18

Expected to finish

2019-01-17

Last updated by the study team

2021-06-30

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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