Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: lotrafilcon B; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965288

EX-MKTG-42

Details and patient eligibility

About

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Full description

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Enrollment: 60 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft toric contact lens wearer
• Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
• Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

Exclusion criteria

A person will be excluded from the study if he/she:

• Has a contact lens prescription outside the range of the available parameters of the study lenses.

• Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.

• Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

• Presence of clinically significant (grade 2-4) anterior segment abnormalities

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • Pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has Presbyopia or has dependence on spectacles for near work over the 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: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

comfilcon A

Experimental group

Description:

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Treatment:

Device: comfilcon A

Device: lotrafilcon B

lotrafilcon B

Active Comparator group

Description:

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Treatment:

Device: comfilcon A

Device: lotrafilcon B

Sponsor of this trial

Lead Sponsor

CooperVision