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

NCT ID: NCT01583868

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

B&L RD2135-01 lens C

Investigational Silicone hydrogel soft contact lens

Group Type: EXPERIMENTAL

B&L RD2135-01 lens C

Intervention Type: DEVICE

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

B&L RD2135-01 lens D

Investigational Silicone hydrogel soft contact lens

Group Type: EXPERIMENTAL

B&L RD2135-01 lens D

Intervention Type: DEVICE

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

PureVision2

Bausch \& Lomb High definition soft contact lenses

Group Type: ACTIVE_COMPARATOR

PureVision2

Intervention Type: DEVICE

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Ciba Vision Air Optix Aqua

Ciba Vision Air Optix Aqua soft contact lens

Group Type: ACTIVE_COMPARATOR

Air Optix Aqua

Intervention Type: DEVICE

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Interventions

B&L RD2135-01 lens C

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Intervention Type: DEVICE

B&L RD2135-01 lens D

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Intervention Type: DEVICE

PureVision2

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Intervention Type: DEVICE

Air Optix Aqua

Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly J Barna, CCRA

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

755E

Identifier Type: -

Identifier Source: org_study_id