Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

CooperVision

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: comfilcon A Toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193178

CV-14-05

Details and patient eligibility

About

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Full description

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had an oculo-visual examination in the last two years

• Is at least 18 years of age and has full legal capacity to volunteer

• Has read and understood the information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/50 or better (in at least one eye)

• Currently wears soft toric contact lenses in both eyes

• Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:

  • -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
  • +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
  • -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
  • -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
  • +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75

• Has clear corneas and no active ocular disease

• Demonstrates an acceptable fit with the study lenses

Exclusion criteria

• Has never worn contact lenses before;
• Has any systemic disease affecting ocular health;
• Is using any systemic or topical medications that will affect ocular health;
• Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
• Has undergone corneal refractive surgery;
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

comfilcon A toric

Experimental group

Description:

Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Treatment:

Device: comfilcon A Toric