Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: filcon IV I (BC 8.6); Device: methafilcon A (BC 8.7); Device: filcon IV I (BC 8.7); Device: somofilcon A; Device: methafilcon A (BC 8.6); Device: ocufilcon D

Study type: Interventional

Funder types: Industry

Identifiers

NCT02727816

EX-MKTG-65

Details and patient eligibility

About

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Full description

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Enrollment: 35 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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 CL (Contact Lens) wearer.
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
• 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.
• Is willing to comply with the visit schedule.

Exclusion criteria

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

• Has never worn contact lenses before.

• Currently wears rigid gas permeable contact lenses.

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

• Has a CL prescription outside the range of - 1.00 to - 6.00D

• Has a spectacle cylinder ≥1.00D of cylinder in either eye.

• 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 (GPC) 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: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

35 participants in 4 patient groups

filcon IV I (BC 8.6) / ocufilcon D (pair one)

Experimental group

Description:

Participants were randomized to a test and control lens for each pair in a contralateral design.

Treatment:

Device: ocufilcon D

Device: filcon IV I (BC 8.6)

filcon IV I (BC 8.7) / ocufilcon D (pair two)

Experimental group

Description:

Participants were randomized to a test and control lens for each pair in a contralateral design.

Treatment:

Device: ocufilcon D

Device: filcon IV I (BC 8.7)

methafilcon A (BC 8.6) / ocufilcon D (pair three)

Experimental group

Description:

Participants were randomized to a test and control lens for each pair in a contralateral design.

Treatment:

Device: methafilcon A (BC 8.6)

Device: ocufilcon D

methafilcon A (BC 8.7) / somofilcon A (pair four)

Experimental group

Description:

Participants were randomized to a test and control lens for each pair in a contralateral design.

Treatment:

Device: somofilcon A

Device: methafilcon A (BC 8.7)