Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Not Applicable

Completed

Brief Summary: Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Detailed Description: 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.

Recruitment & Eligibility

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;

Arm && Interventions

Group	Intervention	Description
fanfilcon A	fanfilcon A	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
enfilcon A	fanfilcon A	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
enfilcon A	enfilcon A	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
fanfilcon A	enfilcon A	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Primary Outcome Measures

Name	Time	Method
Comfort Preference	Dispensing (Baseline) and 2 weeks	Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Comfort (Subjective Rating Scale)	Dispensing (Baseline) and 2 weeks	Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)

Secondary Outcome Measures

Name	Time	Method

Locations (2): Clinical Research Center, University of California, Berkeley
🇺🇸
Berkeley, California, United States
Center for Contact Lens Research, University of Waterloo
🇨🇦
Waterloo, Ontario, Canada