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

Bausch + Lomb

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583868

755E

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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216 participants in 4 patient groups

B&L RD2135-01 lens C

Experimental group

Description:

Investigational Silicone hydrogel soft contact lens

Treatment:

Device: B&L RD2135-01 lens C

B&L RD2135-01 lens D

Experimental group

Description:

Investigational Silicone hydrogel soft contact lens

Treatment:

Device: B&L RD2135-01 lens D

PureVision2

Active Comparator group

Description:

Bausch \& Lomb High definition soft contact lenses

Treatment:

Device: PureVision2

Ciba Vision Air Optix Aqua

Active Comparator group

Description:

Ciba Vision Air Optix Aqua soft contact lens

Treatment:

Device: Air Optix Aqua