Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

NCT ID: NCT02670473

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-05-31

Brief Summary

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Detailed Description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

Conditions

Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

enfilcon A (habitual)

Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

Group Type: NO_INTERVENTION

No interventions assigned to this group

fanfilcon A (test)

Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

Group Type: EXPERIMENTAL

fanfilcon A (test)

Intervention Type: DEVICE

contact lens

Interventions

fanfilcon A (test)

contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Is between 18 and 40 years of age
• Has had a self-reported visual exam in the last two years
• Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
• Has a contact lens spherical prescription between -1.00 to - 6.00
• 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 (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:

• Is not a habitual wearer of enfilcon A lenses
• Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has a history of not achieving comfortable 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 3-4) 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Montés-Mico, O.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Optometry Research Group (GIO) University of Valencia

Locations

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

EX-MKTG-55 (CV-15-09)

Identifier Type: -

Identifier Source: org_study_id