Back to resultsClinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
O2Optix contact lens
Proclear contact lens
ReNu MultiPlus Multi-Purpose Solution
Clear Care Cleaning and Disinfecting Solution
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
02Optix CL and ReNu MPS with SICS
Proclear CL and ReNu MPS with SICS
02Optix CL and Clear Care LCS with SICS
Proclear CL and Clear Care LCS with SICS
02Optix CL and ReNu MPS without SICS
Proclear CL and ReNu MPS without SICS
02Optix CL and Clear Care LCS without SICS
Proclear CL and Clear Care LCS without SICS
Arm Description
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
O2Optix contact lens and Clear Care lens care solution subject
Proclear contact lens and Clear Care lens care solution
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
O2Optix contact lens and Clear Care lens care solution
Proclear contact lens and Clear Care lens care solution
Outcomes
Primary Outcome Measures
Average Daily Wear Time
Average hours per day that contact lens were worn.
Average Daily Comfortable Wear Time
Average hours per day that contact lens were worn comfortably.
Lens Comfort
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
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.
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.
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.
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.
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.
Average Corneal Fluorescein Type Staining
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
Average Corneal Fluorescein Staining Area
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
Limbal Redness
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Bulbar Redness
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Lower Tarsal Redness
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Upper Tarsal Redness
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Tarsal Roughness
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT00813761
First Posted
December 17, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00813761
Brief Title
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2008 (Actual)
Primary Completion Date
August 1, 2009 (Actual)
Study Completion Date
August 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Arm Title
02Optix CL and ReNu MPS with SICS
Arm Type
Other
Arm Description
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Arm Title
Proclear CL and ReNu MPS with SICS
Arm Type
Other
Arm Description
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Arm Title
02Optix CL and Clear Care LCS with SICS
Arm Type
Other
Arm Description
O2Optix contact lens and Clear Care lens care solution subject
Arm Title
Proclear CL and Clear Care LCS with SICS
Arm Type
Other
Arm Description
Proclear contact lens and Clear Care lens care solution
Arm Title
02Optix CL and ReNu MPS without SICS
Arm Type
Other
Arm Description
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Arm Title
Proclear CL and ReNu MPS without SICS
Arm Type
Other
Arm Description
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Arm Title
02Optix CL and Clear Care LCS without SICS
Arm Type
Other
Arm Description
O2Optix contact lens and Clear Care lens care solution
Arm Title
Proclear CL and Clear Care LCS without SICS
Arm Type
Other
Arm Description
Proclear contact lens and Clear Care lens care solution
Intervention Type
Device
Intervention Name(s)
O2Optix contact lens
Intervention Description
control contact lens to be worn daily for approximately 7 months for entire length of study.
Intervention Type
Device
Intervention Name(s)
Proclear contact lens
Intervention Description
control contact lens to be worn for entire length of study.
Intervention Type
Device
Intervention Name(s)
ReNu MultiPlus Multi-Purpose Solution
Intervention Description
lens solution for overnight lens disinfection
Intervention Type
Device
Intervention Name(s)
Clear Care Cleaning and Disinfecting Solution
Intervention Description
lens solution for overnight lens disinfection
Primary Outcome Measure Information:
Title
Average Daily Wear Time
Description
Average hours per day that contact lens were worn.
Time Frame
24 weeks
Title
Average Daily Comfortable Wear Time
Description
Average hours per day that contact lens were worn comfortably.
Time Frame
24 weeks
Title
Lens Comfort
Description
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Time Frame
24 weeks
Title
Frequency of Eye Discomfort
Description
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
Title
Frequency of Daily Lens Dryness
Description
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
Title
Frequency of Eye Burning/Stinging
Description
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
Title
Frequency of Itching
Description
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
Title
Frequency of Tearing
Description
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.
Time Frame
24 weeks
Title
Average Corneal Fluorescein Type Staining
Description
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
Time Frame
24 weeks
Title
Average Corneal Fluorescein Staining Area
Description
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
Time Frame
24 weeks
Title
Limbal Redness
Description
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
24 weeks
Title
Bulbar Redness
Description
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
24 weeks
Title
Lower Tarsal Redness
Description
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
24 weeks
Title
Upper Tarsal Redness
Description
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
24 weeks
Title
Tarsal Roughness
Description
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Intensity of Physiological Outcomes
Description
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
Title
Wearing Time and Comfortable Wearing Time
Description
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
Title
Physiological Responses
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
North Little Rock
State/Province
Arkansas
Country
United States
City
Campbell
State/Province
California
Country
United States
City
Cupertino
State/Province
California
Country
United States
City
Laguna Niguel
State/Province
California
Country
United States
City
Mission Viejo
State/Province
California
Country
United States
City
San Clemente
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Bloomington
State/Province
Illinois
Country
United States
City
Neodesha
State/Province
Kansas
Country
United States
City
Raytown
State/Province
Missouri
Country
United States
City
Warrensburg
State/Province
Missouri
Country
United States
City
Florence
State/Province
New Jersey
Country
United States
City
Chagrin Falls
State/Province
Ohio
Country
United States
City
Warren
State/Province
Ohio
Country
United States
City
Kittanning
State/Province
Pennsylvania
Country
United States
City
Moon
State/Province
Pennsylvania
Country
United States
City
Nanticoke
State/Province
Pennsylvania
Country
United States
City
State College
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Chamberlain
State/Province
South Dakota
Country
United States
City
Bartlett
State/Province
Tennessee
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Midlothian
State/Province
Virginia
Country
United States
City
Virginia Beach
State/Province
Virginia
Country
United States
City
Aston Triangle
State/Province
Birmingham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
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