Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Pair 1 (ocufilcon D / ocufilcon D); Device: Pair 3 (ocufilcon D / comfilcon A); Device: Pair 6 (omafilcon A / comfilcon A); Device: Pair 2 (ocufilcon D / enfilcon A); Device: Pair 5 (methafilcon A / comfilcon A); Device: Pair 4 (methafilcon A / methafilcon A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966770

EX-MKTG-44

Details and patient eligibility

About

The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

Full description

This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

Enrollment: 20 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 contact lens wearer
• Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (diopter) in each eye
• Is correctable to a visual acuity of 20/25 or better in both eyes
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• 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 contact lens wear (5 days per week; > 8 hours/day)
• Has a contact lens prescription outside the range of -1.00 to -6.00D
• Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
• Has best corrected spectacle distance vision worse than 20/25 in either eye
• Has any systemic or topical medications that will affect ocular health
• Has any ocular pathology or severe insufficiency of lacrimal secretion
• Has persistent, clinically significant corneal or conjunctival staining
• Has active neovascularization or any central corneal scars
• Is aphakic
• Is presbyopic
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related conical or research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 6 patient groups

Pair 1 (ocufilcon D / ocufilcon D)

Active Comparator group

Description:

Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)

Treatment:

Device: Pair 1 (ocufilcon D / ocufilcon D)

Pair 2 (ocufilcon D / enfilcon A)

Active Comparator group

Description:

Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)

Treatment:

Device: Pair 2 (ocufilcon D / enfilcon A)

Pair 3 (ocufilcon D / comfilcon A)

Active Comparator group

Description:

Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)

Treatment:

Device: Pair 3 (ocufilcon D / comfilcon A)

Pair 4 (methafilcon A / methafilcon A)

Active Comparator group

Description:

Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)

Treatment:

Device: Pair 4 (methafilcon A / methafilcon A)

Pair 5 (methafilcon A / comfilcon A)

Active Comparator group

Description:

Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)

Treatment:

Device: Pair 5 (methafilcon A / comfilcon A)

Pair 6 (omafilcon A / comfilcon A)

Active Comparator group

Description:

Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)

Treatment:

Device: Pair 6 (omafilcon A / comfilcon A)