Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: narafilcon A; Device: stenfilcon A; Device: delefilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02341859

JP-MKTG-201501

Details and patient eligibility

About

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Full description

The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

Enrollment: 22 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft spherical contact lens wearer
• Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
• Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
• 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
• Patient contact lens refraction should fit within the available parameters of the study lenses
• Is willing to comply with the wear schedule
• Is willing to comply with the visit schedule

Exclusion criteria

• Is not a habitual wearer of soft spherical contact lenses

• Has a contact lens prescription outside the range of the available parameters of the study lenses

• Has a contact lens prescription outside the range of the inclusion power range

• Has a spectacle cylinder ≥1.00D of cylinder in either eye

• Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye

• Presence of clinically significant (grade > 2) anterior segment abnormalities

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear

• Slit lamp findings that would contraindicate contact lens wear such as:

  • Moderate to severe dry eye
  • 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 (past or present)
  • Seborrheic eczema, 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

stenfilcon A and delefilcon A

Active Comparator group

Description:

Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.

Treatment:

Device: delefilcon A

Device: stenfilcon A

stenfilcon A and narafilcon A

Active Comparator group

Description:

Participants randomized wear the stenfilcon A and the narafilcon A contralaterally

Treatment:

Device: stenfilcon A

Device: narafilcon A