N/A
N=25
Dispensing Study for the Phenacite Project
Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT02436005 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Subjective Ratings of Lens Comfort — 86.50; 90.13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Phenacite (Device); comfilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ratings of Lens Comfort |
66.46; 71.71 | — |
| PRIMARY Subjective Ratings of Lens Comfort |
66.46; 71.71 | — |
| PRIMARY Over Refraction for Optimized Distance Acuity |
-0.10; 0.00; -0.02; 0.00 | — |
| PRIMARY Binocular Distance Visual Acuity - High Illumination High Contrast |
-0.19; -0.20 | — |
| PRIMARY Binocular Distance Visual Acuity - High Illumination High Contrast |
-0.19; -0.20 | — |
| PRIMARY Binocular Distance Visual Acuity - Low Illumination High Contrast |
0.00; 0.00 | — |
| PRIMARY Binocular Distance Visual Acuity - Low Illumination High Contrast |
0.00; 0.00 | — |
| PRIMARY Binocular Near Visual Acuity - High Illumination High Contrast |
-0.20; -0.18 | — |
| PRIMARY Binocular Near Visual Acuity - High Illumination High Contrast |
-0.20; -0.18 | — |
| PRIMARY Binocular Near Visual Acuity - Low Illumination High Contrast |
-0.02; -0.03 | — |
| PRIMARY Binocular Near Visual Acuity - Low Illumination High Contrast |
-0.02; -0.03 | — |
| SECONDARY Lens Fit - Post Blink Movement |
0.24; 0.23; 0.25; 0.24 | — |
| SECONDARY Lens Fit - Post Blink Movement |
0.24; 0.23; 0.25; 0.24 | — |
| SECONDARY Push - Up Test for Lens Tightness |
52.83; 49.35; 51.30; 48.70 | — |
| SECONDARY Push - Up Test for Lens Tightness |
52.83; 49.35; 51.30; 48.70 | — |
| SECONDARY Lens Mobility Rating |
2.91; 3.08; 3.00; 3.10 | — |
| SECONDARY Lens Mobility Rating |
2.91; 3.08; 3.00; 3.10 | — |
| SECONDARY Overall Lens Fit Acceptance |
3.25; 3.34; 3.32; 3.36 | — |
| SECONDARY Overall Lens Fit Acceptance |
3.25; 3.34; 3.32; 3.36 | — |
| SECONDARY Subjective Ratings for Vision Quality - Distance Vision |
85.33; 88.88 | — |
| SECONDARY Subjective Ratings for Vision Quality - Distance Vision |
85.33; 88.88 | — |
| SECONDARY Subjective Ratings for Vision Quality - Near Vision |
84.83; 85.88 | — |
| SECONDARY Subjective Ratings for Vision Quality - Near Vision |
84.83; 85.88 | — |
| SECONDARY Subjective Ratings for Vision Quality - Computer Vision |
85.04; 89.08 | — |
| SECONDARY Subjective Ratings for Vision Quality - Computer Vision |
85.04; 89.08 | — |
| SECONDARY Subjective Ratings for Vision Quality - Overall Vision |
85.96; 88.63 | — |
| SECONDARY Subjective Ratings for Vision Quality - Overall Vision |
85.96; 88.63 | — |
| SECONDARY Corneal Staining Extent |
0.02; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Conjunctival Staining |
0.48; 0.38; 0.11; 0.18; 0.00; 0.05 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02436005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.