A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

Not Applicable

Completed

Interventions: Device: PureVision2
Device: B&L RD2135-01 lens C
Device: Air Optix Aqua
Device: B&L RD2135-01 lens D

Brief Summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.

Recruitment & Eligibility

Inclusion Criteria

Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
Must agree to wear the study lenses on a daily wear basis for the duration of the study.
Must be willing to use a lens care system on a regular basis.
If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.

Exclusion Criteria

Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
Any scar or neovascularization within the central 4mm of the cornea.
Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Anisometropia (spherical equivalent) of greater than 2.00 D.
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
Aphakic.
Amblyopic.
Allergic to any component in the study products.
Have had any corneal surgery (ie, refractive surgery).
Currently wear monovision correction, multifocal, or toric contact lenses.
Ocular astigmatism greater than 1.00 D in either eye.

Arm && Interventions

Group	Intervention	Description
PureVision2	PureVision2	Bausch \& Lomb High definition soft contact lenses
B&L RD2135-01 lens C	B&L RD2135-01 lens C	Investigational Silicone hydrogel soft contact lens
Ciba Vision Air Optix Aqua	Air Optix Aqua	Ciba Vision Air Optix Aqua soft contact lens
B&L RD2135-01 lens D	B&L RD2135-01 lens D	Investigational Silicone hydrogel soft contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At 1 week follow up	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms and Complaints	At 1 Week follow up	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.