Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-27

Study Completion Date

2016-12-14

Brief Summary

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Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

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Detailed Description

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The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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fanfilcon A

Participants are randomized to wear fanfilcon A for two weeks during the cross over study.

Group Type ACTIVE_COMPARATOR

fanfilcon A

Intervention Type DEVICE

contact lens

senofilcon A

Participants are randomized to wear senofilcon A for two weeks during the cross over study.

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

contact lens

Interventions

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fanfilcon A

contact lens

Intervention Type DEVICE

senofilcon A

contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

* Is between 18 and 40 years of age (inclusive)
* Has read, understood and signed the information consent letter
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens prescription that fits within the available parameters of the study lenses
* Has a spectacle cylinder no greater than 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
* Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
* Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria

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

* Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day)
* Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings that would contraindicate contact lens wear such as:

* Pathological dry eye or associated findings
* Significant 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 (or history in past year)
* Seborrheic eczema of eyelid region, 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes