A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Not Applicable

Completed

Conditions: Presbyopia

Interventions: Device: comfilcon A Extended Range test lens
Device: comfilcon A control lens

Registration Number: NCT02719353

Lead Sponsor: Coopervision, Inc.

Brief Summary: The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Detailed Description: This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

Inclusion Criteria

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

Has had a self-reported oculo-visual examination in the last two years
Is 50 years of age or greater and has full legal capacity to volunteer
Is able to read and understand the informed consent
Is willing and able to follow instructions and maintain the appointment schedule
Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
Near Add Power requirement of +2.25D or greater
Has spectacle cylinder 0.75 D in both eyes
Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
Has clear corneas and no active ocular disease
Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria

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

Has never worn contact lenses before
Has any systemic disease affecting ocular health
Is using any systemic or topical medications that will affect ocular health
Has any ocular pathology or abnormality that would affect the wearing of contact lenses
Is aphakic (i.e. missing their natural lens inside their eye)
Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
Has undergone corneal refractive surgery
Is participating in any other type of eye related clinical or research study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
comfilcon A Extended Range test lens	comfilcon A control lens	Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
comfilcon A control lens	comfilcon A Extended Range test lens	Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
comfilcon A control lens	comfilcon A control lens	Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
comfilcon A Extended Range test lens	comfilcon A Extended Range test lens	Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	4 days	Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.
Visual Performance	4 days	Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).

Secondary Outcome Measures

Name	Time	Method
Lens Fit	4 days	Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
Bulbar Hyperemia	4 days	Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Subjective Satisfaction	4 days	Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Subjective Ratings for Comfort	4 days	Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Subjective Ratings for Dryness	4 days	Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Lens Handling	4 Days	Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
Average Daily Wearing Time	4 days	Average daily wearing time for test and control lens is assessed in hours.
Limbal Hyperemia	4 days	Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Subjective Preference for Near Vision	4 days	Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
Subjective Preference for Intermediate Vision	4 days	Subjective preference for intermediate vision for test and control contact lenses.
Subjective Preference for Overall Vision	4 days	Subjective preference for overall vision for test and control contact lenses.
Subjective Preference for Comfort	4 days	Subjective preference for comfort for test and control contact lenses.
Subjective Preference for Distance Vision	4 days	Subjective preference for distance vision for test and control contact lenses.
Subjective Overall Lens Preference	4 days	Subjective overall lens preference for test and control contact lenses.