Trial Outcomes & Findings for Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems (NCT NCT00813761)

NCT ID: NCT00813761

Last Updated: 2018-06-19

Results Overview

Average hours per day that contact lens were worn.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 473 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2018-06-19

Participant Flow

Subjects were recruited in both the US and UK and were screened, randomized, and assigned to a study arm.

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.

Participant milestones

Measure	02Optix CL and ReNu MPS O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Proclear CL and ReNu MPS Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	02Optix CL and Clear Care LCS O2Optix contact lens and Clear Care lens care solution	Proclear CL and Clear Care LCS Proclear contact lens and Clear Care lens care solution
Phase 1 (Baseline to 4 Weeks) STARTED	121	103	115	107
Phase 1 (Baseline to 4 Weeks) COMPLETED	117	100	103	105
Phase 1 (Baseline to 4 Weeks) NOT COMPLETED	4	3	12	2
Phase 2 (4 Weeks to 24 Weeks) STARTED	117	100	103	105
Phase 2 (4 Weeks to 24 Weeks) COMPLETED	101	91	94	100
Phase 2 (4 Weeks to 24 Weeks) NOT COMPLETED	16	9	9	5

Reasons for withdrawal

Measure	02Optix CL and ReNu MPS O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Proclear CL and ReNu MPS Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	02Optix CL and Clear Care LCS O2Optix contact lens and Clear Care lens care solution	Proclear CL and Clear Care LCS Proclear contact lens and Clear Care lens care solution
Phase 1 (Baseline to 4 Weeks) Pregnancy	2	0	0	0
Phase 1 (Baseline to 4 Weeks) Lost to Follow-up	0	0	3	1
Phase 1 (Baseline to 4 Weeks) Protocol Violation	1	1	1	0
Phase 1 (Baseline to 4 Weeks) poor vision	0	0	3	0
Phase 1 (Baseline to 4 Weeks) poor comfort	1	1	5	1
Phase 1 (Baseline to 4 Weeks) Withdrawal by Subject	0	1	0	0
Phase 2 (4 Weeks to 24 Weeks) Adverse Event	2	3	0	0
Phase 2 (4 Weeks to 24 Weeks) Lost to Follow-up	3	0	2	1
Phase 2 (4 Weeks to 24 Weeks) Protocol Violation	0	1	0	1
Phase 2 (4 Weeks to 24 Weeks) Poor vision	1	1	1	0
Phase 2 (4 Weeks to 24 Weeks) Poor comfort	1	4	0	3
Phase 2 (4 Weeks to 24 Weeks) Randomization strata filled	9	0	6	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Clear Care LCS n=208 Participants Subjects assigned to Clear Care lens care solution	ReNU MPS n=217 Participants Subjects assigned to ReNU multi purpose solution	Total n=425 Participants Total of all reporting groups
Sex: Female, Male Male	54 Participants n=5 Participants	67 Participants n=7 Participants	121 Participants n=5 Participants
Age, Continuous	33.9 years STANDARD_DEVIATION 11.8 • n=5 Participants	33.4 years STANDARD_DEVIATION 11.3 • n=7 Participants	33.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants	150 Participants n=7 Participants	304 Participants n=5 Participants
Region of Enrollment United States	189 participants n=5 Participants	198 participants n=7 Participants	387 participants n=5 Participants
Region of Enrollment United Kingdom	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

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

Average hours per day that contact lens were worn.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Average Daily Wear Time	13.57 Hours Standard Error 0.23	13.30 Hours Standard Error 0.23	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

Average hours per day that contact lens were worn comfortably.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Average Daily Comfortable Wear Time	11.96 Hours Standard Error 0.29	11.39 Hours Standard Error 0.29	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Lens Comfort	8.63 units on a scale Standard Error 0.13	8.25 units on a scale Standard Error 0.13	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Frequency of Eye Discomfort	0.36 units on a scale Standard Error 0.05	0.46 units on a scale Standard Error 0.05	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Frequency of Daily Lens Dryness	0.66 units on a scale Standard Error 0.05	0.68 units on a scale Standard Error 0.05	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Frequency of Eye Burning/Stinging	0.31 units on a scale Standard Error 0.04	0.31 units on a scale Standard Error 0.04	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Frequency of Itching	0.21 units on a scale Standard Error 0.03	0.21 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=194 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=192 Participants All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Frequency of Tearing	0.16 units on a scale Standard Error 0.03	0.15 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 Eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 Eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Average Corneal Fluorescein Type Staining	0.16 units on a scale Standard Error 0.02	0.36 units on a scale Standard Error 0.02	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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%.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 Eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 Eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Average Corneal Fluorescein Staining Area	0.27 units on a scale Standard Error 0.09	0.99 units on a scale Standard Error 0.09	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Limbal Redness	0.44 units on a scale Standard Error 0.03	0.49 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=387 eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Bulbar Redness	0.50 units on a scale Standard Error 0.03	0.56 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Lower Tarsal Redness	0.51 units on a scale Standard Error 0.03	0.57 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Upper Tarsal Redness	0.48 units on a scale Standard Error 0.03	0.55 units on a scale Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: 24 weeks

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

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

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=388 eyes All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=384 eyes All subjects assigned to ReNU MPS	ReNU MPS (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 MPS (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'.
Tarsal Roughness	0.75 units on a scale Standard Error 0.05	0.87 units on a scale Standard Error 0.05	—	—

SECONDARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=78 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=116 Participants All subjects assigned to ReNU MPS	ReNU MPS (Stainers) n=69 Participants 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 MPS (Non-Stainers) n=123 Participants 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'.
Intensity of Physiological Outcomes Intensity of Discomfort/Pain	2.00 units on a scale Standard Deviation 1.22	2.41 units on a scale Standard Deviation 1.14	2.48 units on a scale Standard Deviation 1.09	2.24 units on a scale Standard Deviation 1.17
Intensity of Physiological Outcomes Intensity of Burning/Stinging	2.24 units on a scale Standard Deviation 1.30	2.10 units on a scale Standard Deviation 1.16	2.35 units on a scale Standard Deviation 1.09	1.76 units on a scale Standard Deviation 1.00
Intensity of Physiological Outcomes Intensity of Dryness	2.20 units on a scale Standard Deviation 0.95	2.69 units on a scale Standard Deviation 1.18	2.40 units on a scale Standard Deviation 1.06	2.25 units on a scale Standard Deviation 1.14
Intensity of Physiological Outcomes Intensity of Itching	1.94 units on a scale Standard Deviation 0.93	1.70 units on a scale Standard Deviation 1.10	2.24 units on a scale Standard Deviation 1.23	1.67 units on a scale Standard Deviation 0.84
Intensity of Physiological Outcomes Intensity of Tearing	2.00 units on a scale Standard Deviation 1.13	1.61 units on a scale Standard Deviation 0.78	2.38 units on a scale Standard Deviation 1.04	1.73 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=78 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=116 Participants All subjects assigned to ReNU MPS	ReNU MPS (Stainers) n=69 Participants 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 MPS (Non-Stainers) n=123 Participants 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'.
Wearing Time and Comfortable Wearing Time Average Wearing Time	14.06 hours Standard Deviation 2.24	13.63 hours Standard Deviation 2.55	13.49 hours Standard Deviation 2.67	13.33 hours Standard Deviation 2.28
Wearing Time and Comfortable Wearing Time Average Comfortable Wearing Time	12.42 hours Standard Deviation 3.17	11.93 hours Standard Deviation 3.47	11.35 hours Standard Deviation 3.35	11.75 hours Standard Deviation 3.67

SECONDARY outcome

Timeframe: 24 weeks

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

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).

Outcome measures

Measure	Clear Care Lens Cleaning Solution (LCS) n=78 Participants All subjects assigned to Clear Care LCS	ReNU Multi Purpose Solution (MPS) n=116 Participants All subjects assigned to ReNU MPS	ReNU MPS (Stainers) n=69 Participants 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 MPS (Non-Stainers) n=123 Participants 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'.
Physiological Responses Corneal Staining	0.20 units on a scale Standard Deviation 0.25	0.11 units on a scale Standard Deviation 0.19	0.52 units on a scale Standard Deviation 0.56	0.32 units on a scale Standard Deviation 0.38
Physiological Responses Limbal Hyperemia	0.52 units on a scale Standard Deviation 0.66	0.39 units on a scale Standard Deviation 0.50	0.46 units on a scale Standard Deviation 0.58	0.43 units on a scale Standard Deviation 0.51
Physiological Responses Bulbar Hyperemia	0.51 units on a scale Standard Deviation 0.59	0.48 units on a scale Standard Deviation 0.54	0.53 units on a scale Standard Deviation 0.62	0.52 units on a scale Standard Deviation 0.59
Physiological Responses Lower Tarsal Hyperemia	0.50 units on a scale Standard Deviation 0.63	0.48 units on a scale Standard Deviation 0.54	0.55 units on a scale Standard Deviation 0.68	0.59 units on a scale Standard Deviation 0.61
Physiological Responses Upper Tarsal Hyperemia	0.51 units on a scale Standard Deviation 0.60	0.46 units on a scale Standard Deviation 0.54	0.51 units on a scale Standard Deviation 0.60	0.59 units on a scale Standard Deviation 0.61
Physiological Responses Tarsal Roughness	0.97 units on a scale Standard Deviation 0.74	0.69 units on a scale Standard Deviation 0.75	0.90 units on a scale Standard Deviation 0.77	0.84 units on a scale Standard Deviation 0.89

Adverse Events

02Optix CL and ReNu MPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proclear CL and ReNu MPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

02Optix CL and Clear Care LCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proclear CL and Clear Care LCS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	02Optix CL and ReNu MPS n=121 participants at risk O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Proclear CL and ReNu MPS n=103 participants at risk Proclear contact lens and ReNu MultiPlus Multi-Purpose	02Optix CL and Clear Care LCS n=115 participants at risk O2Optix contact lens and Clear Care lens care solution	Proclear CL and Clear Care LCS n=107 participants at risk Proclear contact lens and Clear Care lens care solution
Eye disorders Viral Conjunctivitis	0.00% 0/121	0.00% 0/103	0.00% 0/115	0.93% 1/107 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Kristy Canavan, OD

Vistakon

Phone: 1-904-443-1474

Email: kcanava2@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Written consent of the sponsor is required for publication.
• Publication restrictions are in place

Restriction type: OTHER