Clinical trial NCT02436005: Dispensing Study for the Phenacite Project
Official title: Dispensing Study for the Phenacite Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 25
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: Dispensing Study for the Phenacite Project.

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

Detailed description: Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Eligibility criteria: Inclusion Criteria:

* 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 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:

* 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 Visual Acuity
* Is participating in any other type of eye related clinical or research study
* Has participated in study CV-14-32.

Primary outcomes:
measure: Subjective Ratings of Lens Comfort
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Subjective Ratings of Lens Comfort
timeFrame: 2 Weeks
measure: Over Refraction for Optimized Distance Acuity
timeFrame: 2 weeks
measure: Binocular Distance Visual Acuity - High Illumination High Contrast
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Binocular Distance Visual Acuity - High Illumination High Contrast
timeFrame: 2 weeks
measure: Binocular Distance Visual Acuity - Low Illumination High Contrast
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Binocular Distance Visual Acuity - Low Illumination High Contrast
timeFrame: 2 weeks
measure: Binocular Near Visual Acuity - High Illumination High Contrast
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Binocular Near Visual Acuity - High Illumination High Contrast
timeFrame: 2 weeks
measure: Binocular Near Visual Acuity - Low Illumination High Contrast
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Binocular Near Visual Acuity - Low Illumination High Contrast
timeFrame: 2 weeks
Secondary outcomes:
measure: Lens Fit - Post Blink Movement
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Lens Fit - Post Blink Movement
timeFrame: 2 weeks
measure: Push - Up Test for Lens Tightness
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Push - Up Test for Lens Tightness
timeFrame: 2 weeks
measure: Lens Mobility Rating
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Lens Mobility Rating
timeFrame: 2 weeks
measure: Overall Lens Fit Acceptance
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Overall Lens Fit Acceptance
timeFrame: 2 weeks
measure: Subjective Ratings for Vision Quality - Distance Vision
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Subjective Ratings for Vision Quality - Distance Vision
timeFrame: 2 weeks
measure: Subjective Ratings for Vision Quality - Near Vision
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Subjective Ratings for Vision Quality - Near Vision
timeFrame: 2 weeks
measure: Subjective Ratings for Vision Quality - Computer Vision
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Subjective Ratings for Vision Quality - Computer Vision
timeFrame: 2 weeks
measure: Subjective Ratings for Vision Quality - Overall Vision
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Subjective Ratings for Vision Quality - Overall Vision
timeFrame: 2 weeks
measure: Corneal Staining Extent
timeFrame: 2 weeks
measure: Conjunctival Staining
timeFrame: 2 weeks
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: CORL Indiana University
name: Pete Kollbaun, OD PhD
role: PRINCIPAL_INVESTIGATOR
References: