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

Johnson & Johnson Vision Care, Inc.473 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

473

Conditions

Myopia

Interventions

O2Optix contact lensDEVICE

control contact lens to be worn daily for approximately 7 months for entire length of study.

Proclear contact lensDEVICE

control contact lens to be worn for entire length of study.

ReNu MultiPlus Multi-Purpose SolutionDEVICE

lens solution for overnight lens disinfection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Unnamed facility

North Little Rock, Arkansas, United States

Unnamed facility

Campbell, California, United States

Outcomes

Primary Outcomes

Average Daily Wear Time

Average hours per day that contact lens were worn.

Time frame: 24 weeks

Average Daily Comfortable Wear Time

Average hours per day that contact lens were worn comfortably.

Time frame: 24 weeks

Lens Comfort

Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.

Time frame: 24 weeks

Frequency of Eye Discomfort

Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.

Time frame: 24 weeks

Frequency of Daily Lens Dryness

Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.

Time frame: 24 weeks

Frequency of Eye Burning/Stinging

Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.

Time frame: 24 weeks

Frequency of Itching

Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.

Time frame: 24 weeks

Frequency of Tearing

Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.

Data from ClinicalTrials.gov

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Secondary Outcomes

Intensity of Physiological Outcomes

Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5.

Time frame: 24 weeks

Wearing Time and Comfortable Wearing Time

Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.

Time frame: 24 weeks

Physiological Responses

Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).

Time frame: 24 weeks