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

CooperVision

Status: Completed

Conditions: Myopia; Astigmatism; Hyperopia

Treatments: Device: fanfilcon A; Device: enfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02423109

CV-15-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups

fanfilcon A

Experimental group

Description:

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Treatment:

Device: enfilcon A

Device: fanfilcon A

enfilcon A

Active Comparator group

Description:

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Treatment:

Device: enfilcon A

Device: fanfilcon A