Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-03

Study Completion Date

2014-12-11

Brief Summary

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This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.

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Detailed Description

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Conditions

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Corneal Deformity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group 1

1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens

Group Type EXPERIMENTAL

B&L Investigational Contact Lens

Intervention Type DEVICE

The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.

Interventions

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B&L Investigational Contact Lens

The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be between 18 and 40 years of age (inclusive)
* Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
* Able to read, comprehend and sign an informed consent
* Willing to comply with the wear and study visit schedule
* Monocular best-corrected distance visual acuity \>/-20/25 in each eye

Exclusion Criteria

* Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
* Systemic or ocular allergies, which might interfere with contact lens wear
* Systemic disease or condition, which might interfere with contact lens wear
* Use of prescription sleep aids or alcohol within 24 hours of study appointment
* Inability to wear contact lenses
* Under 18 years of age

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes