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Dispensing Study for a New Study Lens

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CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: Phenacite
Device: comfilcon A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02642991
CV-15-41

Details and patient eligibility

About

This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

Full description

This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.

Enrollment

44 patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Oculo-visual examination in the last two years
  • Between 18 and 35 years of age and has full legal capacity to volunteer
  • Has read and understood the informed consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
  • Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
  • Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
  • Has not worn lenses for at least 12 hours before the initial visit
  • Has a subjective response at baseline, which indicates suitability for this study
  • Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
  • Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week

Exclusion criteria

A person will be excluded from the study if he/she:

  • Has never worn contact lenses before
  • Any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
  • Has any ocular pathology or anomaly that would affect the wearing of the lenses
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
  • Is aphakic
  • Has anisometropia of >1.00
  • Has undergone corneal refractive surgery
  • Has strabismus
  • Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
  • Is participating in any other type of eye related clinical or research study
  • Has previously participated in study of the Phenacite lenses

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

44 participants in 2 patient groups

Phenacite Test lens then comfilcon A control lens
Experimental group
Description:
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Treatment:
Device: comfilcon A
Device: Phenacite
Comfilcon A control lens then Phenacite test Lens
Active Comparator group
Description:
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Treatment:
Device: comfilcon A
Device: Phenacite

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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