One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

Completed · Not applicable

Conditions studied: Myopia

In brief

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Key facts

Study ID

NCT02759471

Run by

CooperVision, Inc.

People needed

54

Starts

2016-04-01

Expected to finish

2016-08-01

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older, up to 34. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A person is eligible for inclusion in the study if he/she:
• Is between 18 and 34 years of age (inclusive)
• Has had a self-reported eye exam in the last two years
• Is an adapted comfilcon A sphere contact lens wearer
• Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
• Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
• Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Has a contact lens refraction that fits within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

You may not qualify if…

• A person will be excluded from the study if he/she:
• Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
• Presents with clinically significant anterior segment abnormalities
• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
• Presents with slit lamp findings 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 aphakia, keratoconus or a highly irregular cornea.
• Has presbyopia or has dependence on spectacles for near work over the contact lenses.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.
• Is habitually using rewetting/ lubricating eye drops (more than once per day)

Where it is running

• Golden Optometric Group — Whittier, California, United States
• Complete Eye Care of Medina — Medina, Minnesota, United States
• Sacco Eye Group — Vestal, New York, United States
• Drs. Quinn, Foster, & Associates — Athens, Ohio, United States

Full record on ClinicalTrials.gov

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