N/A
Completed N=51
Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study
Source: ClinicalTrials.gov NCT03519919 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Vision Clarity During the Day - Distance Vision — 22.9; 14.6; 27.1; 68.8 percentage of participants
Summary
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vision Clarity During the Day - Distance Vision |
16.7; 12.5; 18.8; 64.5; 70.8; 64.5 | — |
| SECONDARY Number of Participants With Lens Centration |
32; 16; 0 | — |
| SECONDARY Visual Acuity |
0.00; -0.04 | — |
| SECONDARY Post-blink Lens Movement |
0; 8.3; 77.1; 14.6; 0 | — |
| SECONDARY Corneal Staining |
1.77; 1.04; 1.15; 3.06; 0.75 | — |
| SECONDARY Conjunctival Staining |
16.87; 7.60; 12.7; 11.8 | — |
| SECONDARY Bulbar Hyperemia |
2.05; 1.90 | — |
| SECONDARY Subjective Vision Satisfaction - Driving at Night |
16.7; 64.6; 18.8 | — |
| SECONDARY Subjective Vision Satisfaction - Long Intermediate Vision |
8.3; 66.7; 25.0 | — |
| SECONDARY Subjective Vision Satisfaction - Short Intermediate Tasks |
14.6; 62.5; 22.9 | — |
| SECONDARY Subjective Vision Satisfaction - Near Vision |
16.7; 56.3; 27.0 | — |
| SECONDARY Ease of Insertion |
6.3; 60.4; 33.3 | — |
| SECONDARY Ease of Removal |
14.6; 62.5; 22.9 | — |
| SECONDARY Overall Satisfaction With Speed of Changing Focus |
6.3; 66.7; 27.0 | — |
| SECONDARY Overall Satisfaction Preference Between Study and Habitual Contact Lenses |
14.6; 58.3; 27.1 | — |
| SECONDARY Overall Comfort |
14.6; 10.4; 22.9; 14.6; 37.5 | — |
| SECONDARY Overall Preference Between Study and Habitual Contact Lenses for Lifestyle |
14.5; 14.6; 18.8; 22.9; 29.2 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had a self-reported oculo-visual examination in the last two years.
- Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
- Presently wears lenses for minimum wear 4 days/week and 10 hours/day
- Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
- Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
- Current refraction indicates a reading addition of +1.50 or higher
- Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
- Spends 10 hrs or more indoors at least 5 days/week
- Possesses a smartphone and is willing to download the MetricWire app to receive
Exclusion Criteria
- Is presently wearing Clariti 1 day multifocal lenses
- Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to fluorescein dye or products to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Contact Lens Research
Data sourced from ClinicalTrials.gov (NCT03519919). 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.