Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

CooperVision

Status: Completed

Conditions: Ametropia

Treatments: Device: methafilcon A contact lenses; Device: fanfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03835078

EX-MKTG-98

Details and patient eligibility

About

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Enrollment: 42 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 contact lens wearer
• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
• Have no less than -0.75D (Diopter) of astigmatism 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

• Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses

• Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye

• Has a history of not achieving comfortable Contact Lens (CL) 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

methalfilcon A contact lenses / fanfilcon A contact lenses

Experimental group

Description:

All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.

Treatment:

Device: methafilcon A contact lenses

Device: fanfilcon A contact lenses