Performance Comparison Between Comfilcon A and Senofilcon C 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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-11-23

Brief Summary

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The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

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Detailed Description

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This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

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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comfilcon A

Participants are randomized to wear the comfilcon A lens for one month during the cross over study.

Group Type ACTIVE_COMPARATOR

comfilcon A

Intervention Type DEVICE

contact lens

senofilcon C

Participants are randomized to wear the senofilcon C lens for one month during the cross over study.

Group Type ACTIVE_COMPARATOR

senofilcon C

Intervention Type DEVICE

contact lens

Interventions

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comfilcon A

contact lens

Intervention Type DEVICE

senofilcon C

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 34 years of age (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
* 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
* Has read, understood and signed the information consent letter.
* Has a contact lens prescription that fits within the available parameters of the study lenses.
* Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 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:

* Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; \> 10 hours/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.
* Is participating in any other type of eye related clinical or research study.
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Is currently wearing daily disposable lenses

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes