Clinical trial NCT02423109: Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Official title: Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Comfort (Subjective Rating Scale)
timeFrame: Dispensing (Baseline) and 2 weeks
measure: Comfort Preference
timeFrame: Dispensing (Baseline) and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: Clinical Research Center, University of California, Berkeley
name: Meng Lin, OD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Contact Lens Research, University of Waterloo
name: Lyndon Jones, PhD FCO
role: PRINCIPAL_INVESTIGATOR
References: