Clinical trial NCT02553395: One Week Assessment of The Phenacite Lens
Official title: One Week Assessment of The Phenacite Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.

The study test lens was not the final optical design and the study results were not used for the design validation.

Detailed description: This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Eligibility criteria: 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 (Diopter) and -4.50D
  * Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75
  * 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.
  * Has any systemic disease affecting ocular health.
  * Is using any systemic or topical medications that will affect ocular health.
  * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  * Is aphakic.
  * Has undergone corneal refractive surgery.
  * Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
timeFrame: Baseline - After 5 minutes of lens settling
measure: Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
timeFrame: 1 week
measure: Binocular Near Visual Acuity (VA) - High Illumination High Contrast
timeFrame: Baseline - after 5 minutes of lens dispense
measure: Binocular Near Visual Acuity (VA) - High Illumination High Contrast
timeFrame: 1-week
measure: Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
timeFrame: Baseline (After 5 minutes of lens settling)
measure: Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
timeFrame: 1 week
measure: Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
timeFrame: Baseline (after 5 minutes of lens settling)
measure: Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
timeFrame: 1week
measure: Subjective Ratings for Distance Quality of Vision
timeFrame: 1 week
measure: Subjective Ratings for Intermediate Quality of Vision
timeFrame: 1 week
measure: Subjective Ratings for Near Quality of Vision
timeFrame: 1 week
Secondary outcomes:
measure: Post Blink Movement -
timeFrame: Baseline (After 5 minutes of lens dispense)
measure: Post Blink Movement
timeFrame: 1 week
measure: Push - Up Test for Lens Tightness
timeFrame: Baseline (After 5 minutes of lens dispense)
measure: Push - Up Test for Lens Tightness
timeFrame: 1 week
measure: Lens Mobility Rating
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Lens Mobility Rating
timeFrame: 1 week
measure: Overall Lens Fit Acceptance
timeFrame: Baseline (After 5 minutes of lens dispense)
measure: Overall Lens Fit Acceptance
timeFrame: 1 week
measure: Subjective Lens Preference - Distance Vision
timeFrame: 1 week
measure: Subjective Lens Preference -Overall Vision Preference
timeFrame: 1 week
measure: Subjective Lens Preference - Comfort
timeFrame: 1 week
measure: Subjective Overall Lens Preference
timeFrame: 1 week
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
affiliation: Clinical Optics Research Lab (CORL)
name: Peter Kollbaum, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: