N/A
Completed N=44
Dispensing Study for a New Study Lens
Source: ClinicalTrials.gov NCT02642991 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Distance Visual Acuity (VA) - High Illumination — -0.10; -0.11; -0.15; -0.17 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) - High Illumination |
-0.10; -0.11; -0.15; -0.16 | — |
| PRIMARY Distance Visual Acuity (VA) - High Illumination |
-0.10; -0.11; -0.15; -0.16 | — |
| PRIMARY Near Visual Acuity (VA) - High Illumination |
-0.06; -0.07; -0.11; -0.13 | — |
| PRIMARY Near Visual Acuity (VA) - High Illumination |
-0.06; -0.07; -0.11; -0.13 | — |
| PRIMARY Distance Visual Acuity (VA) - Low Illumination |
0.06; 0.05; -0.01; 0.01 | — |
| PRIMARY Distance Visual Acuity (VA) - Low Illumination |
0.06; 0.05; -0.01; 0.01 | — |
| PRIMARY Near Visual Acuity (VA) - Low Illumination |
0.16; 0.18; 0.09; 0.11 | — |
| PRIMARY Near Visual Acuity (VA) - Low Illumination |
0.16; 0.18; 0.09; 0.11 | — |
| PRIMARY Quality of Distance Vision |
87; 90 | — |
| PRIMARY Quality of Distance Vision |
87; 90 | — |
| PRIMARY Quality of Near Vision |
90; 90 | — |
| PRIMARY Quality of Near Vision |
90; 90 | — |
| PRIMARY Quality of Vision With Digital Device Use |
91; 90 | — |
| PRIMARY Quality of Vision With Digital Device Use |
91; 90 | — |
| PRIMARY Quality of Intermediate Vision |
92; 92 | — |
| PRIMARY Quality of Intermediate Vision |
92; 92 | — |
| PRIMARY Overall Vision Quality |
88; 89 | — |
| PRIMARY Overall Vision Quality |
88; 89 | — |
| SECONDARY Biomicroscopy Findings - Bulbar Hyperemia |
1.24; 1.37 | — |
| SECONDARY Biomicroscopy Findings- Limbal Hyperemia |
0.98; 1.21 | — |
| SECONDARY Biomicroscopy Findings - Corneal Staining Extent |
0.05; 0.10; 0.14; 0.16; 0.07; 0.03 | — |
| SECONDARY Ghosting - Distance Vision |
93; 93 | — |
| SECONDARY Ghosting - Near Vision |
93; 93 | — |
| SECONDARY Overall Comfort |
78; 79 | — |
| SECONDARY Overall Comfort |
78; 79 | — |
| SECONDARY Overall Dryness |
76; 77 | — |
| SECONDARY Overall Dryness |
76; 77 | — |
| SECONDARY Lens Preference - Overall Vision Preference |
14; 25; 5 | — |
| SECONDARY Subjective Ratings of Change in Frequency of Tiredness |
11; 18; 50; 39; 36; 39 | — |
| SECONDARY Subjective Ratings of Change in Severity of Tiredness |
17; 17; 48; 39; 26; 35 | — |
| SECONDARY Subjective Ratings of Change in Bothersome Rating for Tiredness |
20; 10; 45; 45; 35; 40 | — |
| SECONDARY Subjective Ratings of Change in Frequency of Dryness |
15; 20; 35; 15; 25; 35 | — |
| SECONDARY Subjective Ratings of Change in Severity of Dryness |
9; 5; 41; 41; 32; 27 | — |
| SECONDARY Subjective Ratings of Change in Bothersome Rating of Dryness |
15; 10; 40; 40; 25; 25 | — |
| SECONDARY Subjective Questionnaire Response - Eye Strain |
75; 75; 25; 25 | — |
| SECONDARY Subjective Questionnaire Response - Eye Feel Good |
86; 71; 14; 29 | — |
| SECONDARY Subjective Questionnaire Response - Eye Feel Relaxed |
79; 79; 21; 21 | — |
| SECONDARY Subjective Questionnaire Response - Vision |
96; 96; 4; 4 | — |
| SECONDARY Subjective Questionnaire Response - Eye Tired |
82; 75; 18; 25 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02642991). 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.