Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: O2Optix contact lens; Device: Clear Care Cleaning and Disinfecting Solution; Device: Proclear contact lens; Device: ReNu MultiPlus Multi-Purpose Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813761

CR-4522

Details and patient eligibility

About

The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Enrollment: 473 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years old.
• Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
• Require a visual correction in both eyes (monovision allowed but not monofit).
• Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
• Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
• Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
• Have normal eyes with no evidence of abnormality or disease.

Exclusion criteria

• Requires concurrent ocular medication.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
• Worn lenses on an extended wear basis in the last 3 months.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
• Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
• Abnormal lacrimal secretions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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473 participants in 8 patient groups

02Optix CL and ReNu MPS with SICS

Other group

Description:

O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution

Treatment:

Device: O2Optix contact lens

Device: ReNu MultiPlus Multi-Purpose Solution

Proclear CL and ReNu MPS with SICS

Other group

Description:

Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution

Treatment:

Device: Proclear contact lens

Device: ReNu MultiPlus Multi-Purpose Solution

02Optix CL and Clear Care LCS with SICS

Other group

Description:

O2Optix contact lens and Clear Care lens care solution subject

Treatment:

Device: O2Optix contact lens

Device: Clear Care Cleaning and Disinfecting Solution

Proclear CL and Clear Care LCS with SICS

Other group

Description:

Proclear contact lens and Clear Care lens care solution

Treatment:

Device: Proclear contact lens

Device: Clear Care Cleaning and Disinfecting Solution

02Optix CL and ReNu MPS without SICS

Other group

Description:

O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution

Treatment:

Device: O2Optix contact lens

Device: ReNu MultiPlus Multi-Purpose Solution

Proclear CL and ReNu MPS without SICS

Other group

Description:

Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution

Treatment:

Device: Proclear contact lens

Device: ReNu MultiPlus Multi-Purpose Solution

02Optix CL and Clear Care LCS without SICS

Other group

Description:

O2Optix contact lens and Clear Care lens care solution

Treatment:

Device: O2Optix contact lens

Device: Clear Care Cleaning and Disinfecting Solution

Proclear CL and Clear Care LCS without SICS

Other group

Description:

Proclear contact lens and Clear Care lens care solution

Treatment:

Device: Proclear contact lens

Device: Clear Care Cleaning and Disinfecting Solution