Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Status: | Completed |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 17 - Any |
Updated: | 1/12/2018 |
Start Date: | September 2015 |
End Date: | March 2016 |
Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens
over two weeks.
over two weeks.
Evaluation of the clinical performance of an investigational silicone-hydrogel lens called
fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called
enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized,
bilateral, cross-over, dispensing study.
fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called
enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized,
bilateral, cross-over, dispensing study.
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;
We found this trial at
2
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