N/A
Completed N=51
Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
Source: ClinicalTrials.gov NCT04305912 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Subjective Ratings for Lens Handling for Lens Insertion — 9.3; 9.2 units on a scale
Summary
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ratings for Lens Handling for Lens Insertion |
9.3; 9.2 | — |
| PRIMARY Subjective Ratings for Lens Handling for Lens Removal |
9.1; 8.8 | — |
| SECONDARY Lens Fit - Centration |
0.5; 0.3 | — |
| SECONDARY Lens Fit - Post-blink Movement |
0.2; 0.2 | — |
| SECONDARY Lens Fit - Lens Push-up Tightness |
51; 51 | — |
Eligibility Criteria
Inclusion Criteria
-
A person is eligible for inclusion in the study if he/she:
- 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;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Has an astigmatism of ≤ 1.00 D in subjective refraction;
- Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria
-
A person may be excluded from the study if he/she:
- 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 the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research & Education;
- Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
- Has participated in any clinical trials within a week prior to the study.
Data sourced from ClinicalTrials.gov (NCT04305912). 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.