Clinical trial NCT02642991: Dispensing Study for a New Study Lens
Official title: Dispensing Study for The Phenacite Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-12-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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 (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

Primary outcomes:
measure: Distance Visual Acuity (VA) - High Illumination
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Distance Visual Acuity (VA) - High Illumination
timeFrame: 1 week
measure: Near Visual Acuity (VA) - High Illumination
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Near Visual Acuity (VA) - High Illumination
timeFrame: 1 week
measure: Distance Visual Acuity (VA) - Low Illumination
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Distance Visual Acuity (VA) - Low Illumination
timeFrame: 1 week
measure: Near Visual Acuity (VA) - Low Illumination
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Near Visual Acuity (VA) - Low Illumination
timeFrame: 1 week
measure: Quality of Distance Vision
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Quality of Distance Vision
timeFrame: 1 week
measure: Quality of Near Vision
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Quality of Near Vision
timeFrame: 1 week
measure: Quality of Vision With Digital Device Use
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Quality of Vision With Digital Device Use
timeFrame: 1 week
measure: Quality of Intermediate Vision
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Quality of Intermediate Vision
timeFrame: 1 week
measure: Overall Vision Quality
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Overall Vision Quality
timeFrame: 1 week
Secondary outcomes:
measure: Biomicroscopy Findings - Bulbar Hyperemia
timeFrame: 1 week
measure: Biomicroscopy Findings- Limbal Hyperemia
timeFrame: 1 week
measure: Biomicroscopy Findings - Corneal Staining Extent
timeFrame: 1 week
measure: Ghosting - Distance Vision
timeFrame: 1 week
measure: Ghosting - Near Vision
timeFrame: 1 week
measure: Overall Comfort
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Overall Comfort
timeFrame: 1 week
measure: Overall Dryness
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Overall Dryness
timeFrame: 1 week
measure: Lens Preference - Overall Vision Preference
timeFrame: 1 week
measure: Subjective Ratings of Change in Frequency of Tiredness
timeFrame: 1 week
measure: Subjective Ratings of Change in Severity of Tiredness
timeFrame: 1 week
measure: Subjective Ratings of Change in Bothersome Rating for Tiredness
timeFrame: 1 week
measure: Subjective Ratings of Change in Frequency of Dryness
timeFrame: 1 week
measure: Subjective Ratings of Change in Severity of Dryness
timeFrame: 1 week
measure: Subjective Ratings of Change in Bothersome Rating of Dryness
timeFrame: 1 week
measure: Subjective Questionnaire Response - Eye Strain
timeFrame: 1 week
measure: Subjective Questionnaire Response - Eye Feel Good
timeFrame: 1 week
measure: Subjective Questionnaire Response - Eye Feel Relaxed
timeFrame: 1 week
measure: Subjective Questionnaire Response - Vision
timeFrame: 1 week
measure: Subjective Questionnaire Response - Eye Tired
timeFrame: 1 week
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
city: Bloomington
country: United States
facility: CORL, Indiana University
state: Indiana
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: CCLR, University of Waterloo
name: Lyndon Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: CORL, Indiana University
name: Pete Kollbaum, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRC, University of California, Berkeley
name: Meng Lin, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: