N/A
N=33
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Myopia · Hyperopia · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02423109 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Comfort (Subjective Rating Scale) — 87; 88; 79; 76 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fanfilcon A (Device); enfilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort (Subjective Rating Scale) |
87; 88; 79; 76 | — |
| PRIMARY Comfort Preference |
12; 14; 10; 12; 9; 5 | — |
Summary
Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.
Eligibility Criteria
Inclusion Criteria
- Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
- Have read and signed an information consent letter;
- Are willing and able to follow instructions and maintain the appointment schedule;
- Are an adapted soft contact lens wearer;
- Require spectacle lens powers in both eyes;
- Sphere: between -0.50 to -6.00 diopters and
- Astigmatism: between -1.25 to -2.00 and
- Axis: 180 ± 20 degrees
- Are willing to wear contact lens in both eyes;
- Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
- To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;
Exclusion Criteria
- Are participating in any concurrent clinical or research study;
- Have any known active* ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Are aphakic;
- Have undergone refractive error surgery;
Data sourced from ClinicalTrials.gov (NCT02423109). 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.