N/A
Completed N=30
One Week Assessment of The Phenacite Lens
Source: ClinicalTrials.gov NCT02553395 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Binocular Distance Visual Acuity (VA) - High Illumination High Contrast — -0.22; -0.24 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Visual Acuity (VA) - High Illumination High Contrast |
-0.22; -0.24 | — |
| PRIMARY Binocular Distance Visual Acuity (VA) -High Illumination High Contrast |
-0.20; -0.22 | — |
| PRIMARY Binocular Near Visual Acuity (VA) - High Illumination High Contrast |
-0.19; -0.19 | — |
| PRIMARY Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast |
0.00; -0.04 | — |
| PRIMARY Binocular Near Visual Acuity (VA) - Low Illumination High Contrast |
-0.01; -0.00 | — |
| PRIMARY Subjective Ratings for Distance Quality of Vision |
85; 91 | — |
| PRIMARY Subjective Ratings for Intermediate Quality of Vision |
91; 95 | — |
| PRIMARY Subjective Ratings for Near Quality of Vision |
92; 95 | — |
| SECONDARY Post Blink Movement - |
0.23; 0.24; 0.23; 0.25 | — |
| SECONDARY Post Blink Movement |
0.24; 0.24; 0.25; 0.25 | — |
| SECONDARY Push - Up Test for Lens Tightness |
50.33; 49.17; 49.33; 49.17 | — |
| SECONDARY Lens Mobility Rating |
2.98; 3.04; 3.02; 3.04 | — |
| SECONDARY Overall Lens Fit Acceptance |
3.42; 3.48; 3.35; 3.49 | — |
| SECONDARY Subjective Lens Preference - Distance Vision |
17; 50; 33 | — |
| SECONDARY Subjective Lens Preference -Overall Vision Preference |
27; 56; 17 | — |
| SECONDARY Subjective Lens Preference - Comfort |
43; 40; 17 | — |
| SECONDARY Subjective Overall Lens Preference |
33; 57; 10 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02553395). 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. Informational only — not medical advice.