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A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

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CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: Test Lens
Device: Control Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03235089
CV-17-46

Details and patient eligibility

About

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Full description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read, fully understood and signed the information consent letter
  • Currently wears or has previously worn soft contact lenses
  • Has spectacle cylinder ≤1.00D in both eyes.
  • Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
  • Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
  • Has clear corneas and no active ocular disease
  • Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion criteria

  • Has never worn contact lenses before
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  • Has any known active ocular disease and/or infection
  • Has a monovision correction
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
  • Is aphakic
  • Has undergone corneal refractive surgery
  • Is pregnant or lactating, determined by self-report

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

Test lens
Active Comparator group
Description:
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Treatment:
Device: Test Lens
Device: Control Lens
nelfilcon A lens (control)
Active Comparator group
Description:
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Treatment:
Device: Test Lens
Device: Control Lens

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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