A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

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Detailed Description

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Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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comfilcon A

Daily wear soft contact lens comfilcon A

Group Type ACTIVE_COMPARATOR

lotrafilcon B

Intervention Type DEVICE

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

lotrafilcon B

Daily wear soft contact lens lotrafilcon B

Group Type ACTIVE_COMPARATOR

comfilcon A

Intervention Type DEVICE

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

Interventions

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comfilcon A

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

Intervention Type DEVICE

lotrafilcon B

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is between 18 and 40 years of age (inclusive)
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL wearer
* Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
* Has less than 0.75D spectacle cylinder 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 (at least 40 hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of - 1.00 to -9.00D
* Has a spectacle cylinder greater than -0.50D of cylinder in either eye
* Has best corrected spectacle distance vision worse then 20/25 in either eye
* Has any systemic disease affecting ocular health
* Is using 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 clinical or research study

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No