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

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00813761
• Collaborator: (none)
• Enrollment: 473
• Locations: 26
• Arms: 8
• Actual Duration (Months): 11
• Patients Per Site: 18.2
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: O2Optix contact lens; Device: Proclear contact lens; Device: ReNu MultiPlus Multi-Purpose Solution; Device: Clear Care Cleaning and Disinfecting Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 473 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 02Optix CL and ReNu MPS with SICS O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: O2Optix contact lens; control contact lens to be worn daily for approximately 7 months for entire length of study.; Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection
Other: Proclear CL and ReNu MPS with SICS Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: Proclear contact lens; control contact lens to be worn for entire length of study.; Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection
Other: 02Optix CL and Clear Care LCS with SICS O2Optix contact lens and Clear Care lens care solution subject	Device: O2Optix contact lens; control contact lens to be worn daily for approximately 7 months for entire length of study.; Device: Clear Care Cleaning and Disinfecting Solution; lens solution for overnight lens disinfection
Other: Proclear CL and Clear Care LCS with SICS Proclear contact lens and Clear Care lens care solution	Device: Proclear contact lens; control contact lens to be worn for entire length of study.; Device: Clear Care Cleaning and Disinfecting Solution; lens solution for overnight lens disinfection
Other: 02Optix CL and ReNu MPS without SICS O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: O2Optix contact lens; control contact lens to be worn daily for approximately 7 months for entire length of study.; Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection
Other: Proclear CL and ReNu MPS without SICS Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: Proclear contact lens; control contact lens to be worn for entire length of study.; Device: ReNu MultiPlus Multi-Purpose Solution; lens solution for overnight lens disinfection
Other: 02Optix CL and Clear Care LCS without SICS O2Optix contact lens and Clear Care lens care solution	Device: O2Optix contact lens; control contact lens to be worn daily for approximately 7 months for entire length of study.; Device: Clear Care Cleaning and Disinfecting Solution; lens solution for overnight lens disinfection
Other: Proclear CL and Clear Care LCS without SICS Proclear contact lens and Clear Care lens care solution	Device: Proclear contact lens; control contact lens to be worn for entire length of study.; Device: Clear Care Cleaning and Disinfecting Solution; lens solution for overnight lens disinfection

Outcome Measures

Primary Outcome Measures

1. Average Daily Wear Time [24 weeks]

   Average hours per day that contact lens were worn.

2. Average Daily Comfortable Wear Time [24 weeks]

   Average hours per day that contact lens were worn comfortably.

3. Lens Comfort [24 weeks]

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

4. Frequency of Eye Discomfort [24 weeks]

   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.

5. Frequency of Daily Lens Dryness [24 weeks]

   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.

6. Frequency of Eye Burning/Stinging [24 weeks]

   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.

7. Frequency of Itching [24 weeks]

   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.

8. Frequency of Tearing [24 weeks]

   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.

9. Average Corneal Fluorescein Type Staining [24 weeks]

   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.

10. Average Corneal Fluorescein Staining Area [24 weeks]

    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%.

11. Limbal Redness [24 weeks]

    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

12. Bulbar Redness [24 weeks]

    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

13. Lower Tarsal Redness [24 weeks]

    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

14. Upper Tarsal Redness [24 weeks]

    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

15. Tarsal Roughness [24 weeks]

    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

1. Intensity of Physiological Outcomes [24 weeks]

   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.

2. Wearing Time and Comfortable Wearing Time [24 weeks]

   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.

3. Physiological Responses [24 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		North Little Rock	Arkansas	United States
2		Campbell	California	United States
3		Cupertino	California	United States
4		Laguna Niguel	California	United States
5		Mission Viejo	California	United States
6		San Clemente	California	United States
7		Colorado Springs	Colorado	United States
8		Bloomington	Illinois	United States
9		Neodesha	Kansas	United States
10		Raytown	Missouri	United States
11		Warrensburg	Missouri	United States
12		Florence	New Jersey	United States
13		Chagrin Falls	Ohio	United States
14		Warren	Ohio	United States
15		Kittanning	Pennsylvania	United States
16		Moon	Pennsylvania	United States
17		Nanticoke	Pennsylvania	United States
18		State College	Pennsylvania	United States
19		Warwick	Rhode Island	United States
20		Chamberlain	South Dakota	United States
21		Bartlett	Tennessee	United States
22		Salt Lake City	Utah	United States
23		Burlington	Vermont	United States
24		Midlothian	Virginia	United States
25		Virginia Beach	Virginia	United States
26		Aston Triangle	Birmingham	United Kingdom

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00813761
• Other Study ID Numbers: CR-4522
• First Posted: Dec 23, 2008
• Last Update Posted: Jun 19, 2018
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Myopia; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited in both the US and UK and were screened, randomized, and assigned to a study arm.
Pre-assignment Detail	A total of 473 subjects were attempted to be enrolled. There were 27 disqualified, 2 due to incorrect care system, 1 due to non-compliance, and 24 due to non-compliance from investigator, leaving 446 subjects recruited to participate.Of those remaining, 21 failed to meet inclusion or were excluded for a total of 425 subjects who started the study.

Arm/Group Title	02Optix CL and ReNu MPS	Proclear CL and ReNu MPS	02Optix CL and Clear Care LCS	Proclear CL and Clear Care LCS
Arm/Group 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	Proclear contact lens and Clear Care lens care solution
Period Title: Phase 1 (Baseline to 4 Weeks)
STARTED	121	103	115	107
COMPLETED	117	100	103	105
NOT COMPLETED	4	3	12	2
Period Title: Phase 1 (Baseline to 4 Weeks)
STARTED	117	100	103	105
COMPLETED	101	91	94	100
NOT COMPLETED	16	9	9	5

Baseline Characteristics

Arm/Group Title	Clear Care LCS	ReNU MPS	Total
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution	Total of all reporting groups
Overall Participants	208	217	425
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.9 (11.8)	33.4 (11.3)	33.6 (11.6)
Sex: Female, Male (Count of Participants)
Female	154 74%	150 69.1%	304 71.5%
Male	54 26%	67 30.9%	121 28.5%
Region of Enrollment (participants) [Number]
United States	189 90.9%	198 91.2%	387 91.1%
United Kingdom	19 9.1%	19 8.8%	38 8.9%

Outcome Measures

1. Primary Outcome

Title	Average Daily Wear Time
Description	Average hours per day that contact lens were worn.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care Lens Cleaning Solution (LCS)	ReNU Multi Purpose Solution (MPS)
Arm/Group Description	All subjects assigned to Clear Care LCS	All subjects assigned to ReNU MPS
Measure Participants	194	192
Least Squares Mean (Standard Error) [Hours]	13.57 (0.23)	13.30 (0.23)

2. Primary Outcome

Title	Average Daily Comfortable Wear Time
Description	Average hours per day that contact lens were worn comfortably.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [Hours]	11.96 (0.29)	11.39 (0.29)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	8.63 (0.13)	8.25 (0.13)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	0.36 (0.05)	0.46 (0.05)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	0.66 (0.05)	0.68 (0.05)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	0.31 (0.04)	0.31 (0.04)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	0.21 (0.03)	0.21 (0.03)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Least Squares Mean (Standard Error) [units on a scale]	0.16 (0.03)	0.15 (0.03)

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure Eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.16 (0.02)	0.36 (0.02)

10. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure Eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.27 (0.09)	0.99 (0.09)

11. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.44 (0.03)	0.49 (0.03)

12. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure eyes	388	387
Least Squares Mean (Standard Error) [units on a scale]	0.50 (0.03)	0.56 (0.03)

13. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.51 (0.03)	0.57 (0.03)

14. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.48 (0.03)	0.55 (0.03)

15. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Arm/Group Title	Clear Care LCS	ReNU MPS
Arm/Group Description	Subjects assigned to Clear Care lens care solution	Subjects assigned to ReNU multi purpose solution
Measure Participants	194	192
Measure eyes	388	384
Least Squares Mean (Standard Error) [units on a scale]	0.75 (0.05)	0.87 (0.05)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.

Arm/Group Title	Clear Care LCS (Stainers)	Clear Care LCS (Non-Stainers)	ReNU MPS (Stainers)	ReNU MPS (Non-Stainers)
Arm/Group Description	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
Measure Participants	78	116	69	123
Intensity of Discomfort/Pain	2.00 (1.22)	2.41 (1.14)	2.48 (1.09)	2.24 (1.17)
Intensity of Burning/Stinging	2.24 (1.30)	2.10 (1.16)	2.35 (1.09)	1.76 (1.00)
Intensity of Dryness	2.20 (0.95)	2.69 (1.18)	2.40 (1.06)	2.25 (1.14)
Intensity of Itching	1.94 (0.93)	1.70 (1.10)	2.24 (1.23)	1.67 (0.84)
Intensity of Tearing	2.00 (1.13)	1.61 (0.78)	2.38 (1.04)	1.73 (0.79)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.

Arm/Group Title	Clear Care LCS (Stainers)	Clear Care LCS (Non-Stainers)	ReNU MPS (Stainers)	ReNU MPS (Non-Stainers)
Arm/Group Description	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
Measure Participants	78	116	69	123
Average Wearing Time	14.06 (2.24)	13.63 (2.55)	13.49 (2.67)	13.33 (2.28)
Average Comfortable Wearing Time	12.42 (3.17)	11.93 (3.47)	11.35 (3.35)	11.75 (3.67)

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.

Arm/Group Title	Clear Care LCS (Stainers)	Clear Care LCS (Non-Stainers)	ReNU MPS (Stainers)	ReNU MPS (Non-Stainers)
Arm/Group Description	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.	ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
Measure Participants	78	116	69	123
Corneal Staining	0.20 (0.25)	0.11 (0.19)	0.52 (0.56)	0.32 (0.38)
Limbal Hyperemia	0.52 (0.66)	0.39 (0.50)	0.46 (0.58)	0.43 (0.51)
Bulbar Hyperemia	0.51 (0.59)	0.48 (0.54)	0.53 (0.62)	0.52 (0.59)
Lower Tarsal Hyperemia	0.50 (0.63)	0.48 (0.54)	0.55 (0.68)	0.59 (0.61)
Upper Tarsal Hyperemia	0.51 (0.60)	0.46 (0.54)	0.51 (0.60)	0.59 (0.61)
Tarsal Roughness	0.97 (0.74)	0.69 (0.75)	0.90 (0.77)	0.84 (0.89)

Adverse Events

Arm/Group Title	02Optix CL and ReNu MPS		Proclear CL and ReNu MPS		02Optix CL and Clear Care LCS		Proclear CL and Clear Care LCS
Arm/Group Description	O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution		Proclear contact lens and ReNu MultiPlus Multi-Purpose		O2Optix contact lens and Clear Care lens care solution		Proclear contact lens and Clear Care lens care solution
All Cause Mortality
	02Optix CL and ReNu MPS		Proclear CL and ReNu MPS		02Optix CL and Clear Care LCS		Proclear CL and Clear Care LCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	02Optix CL and ReNu MPS		Proclear CL and ReNu MPS		02Optix CL and Clear Care LCS		Proclear CL and Clear Care LCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/103 (0%)		0/115 (0%)		1/107 (0.9%)
Eye disorders
Viral Conjunctivitis	0/121 (0%)	0	0/103 (0%)	0	0/115 (0%)	0	1/107 (0.9%)	1
Other (Not Including Serious) Adverse Events
	02Optix CL and ReNu MPS		Proclear CL and ReNu MPS		02Optix CL and Clear Care LCS		Proclear CL and Clear Care LCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/103 (0%)		0/115 (0%)		0/107 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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