N/A
N=56
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04195893 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Lens Handling for Lens Insertion — 9.3; 8.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- somofilcon A (Device); etafilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling for Lens Insertion |
9.4; 8.1 | — |
| PRIMARY Lens Handling for Lens Insertion |
9.4; 8.1 | — |
| PRIMARY Lens Handling for Lens Insertion |
9.4; 8.1 | — |
| PRIMARY Lens Handling for Lens Insertion |
9.4; 8.1 | — |
| PRIMARY Lens Handling for Lens Removal |
9.4; 9.3 | — |
| PRIMARY Lens Handling for Lens Removal |
9.4; 9.3 | — |
| PRIMARY Lens Handling for Lens Removal |
9.4; 9.3 | — |
| PRIMARY Lens Handling for Lens Removal |
9.4; 9.3 | — |
| SECONDARY Lens Centration |
0.7; 0.8 | — |
| SECONDARY Lens Centration |
0.7; 0.8 | — |
| SECONDARY Post-blink Movement |
0.3; 0.3 | — |
| SECONDARY Post-blink Movement |
0.3; 0.3 | — |
| SECONDARY Push-up Tightness |
52; 48 | — |
| SECONDARY Push-up Tightness |
52; 48 | — |
Summary
The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.
Eligibility Criteria
Inclusion Criteria
- Subjects will only be eligible for the study if:
- 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 silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria
- Subjects will not be eligible to take part in the study if:
- 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 (verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research & Education;
- Has participated in the BEAGLE (EX-MKTG-104) study.
Data sourced from ClinicalTrials.gov (NCT04195893). 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.