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

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CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: comfilcon A asphere lens (test)
Device: comfilcon A sphere lens (control)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02759471
EX-MKTG-63

Details and patient eligibility

About

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.

Full description

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. Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Enrollment

54 patients

Sex

All

Ages

18 to 34 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion Criteria

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

54 participants in 2 patient groups

comfilcon A asphere (test)
Experimental group
Description:
Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
Treatment:
Device: comfilcon A asphere lens (test)
comfilcon A sphere (control)
Active Comparator group
Description:
Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
Treatment:
Device: comfilcon A sphere lens (control)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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