Clinical Evaluation of the Safety and Efficacy of FID 120947A

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02771145
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: FID 120947A contact lens disinfecting solution; Device: Soft contact lenses (SCL); Device: SCL preservative solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Actual Study Start Date: May 20, 2016
• Actual Primary Completion Date: Jan 10, 2017
• Actual Study Completion Date: Jan 10, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: FID 120947A FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.

Device: FID 120947A contact lens disinfecting solution; Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses; Other Names: Clear Care® Plus ; Device: Soft contact lenses (SCL); Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.; Other Names: 2-Week Acuvue® ; Device: SCL preservative solution; Commercially available solution for rinsing soft contact lenses

Outcome Measures

Primary Outcome Measures

1. Percentage of Eyes With Visibly Clean Lenses at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. Both eyes contributed to the analysis.

2. Number of Eyes With Film Deposits on Lens by Type at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.

3. Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.

4. Percentage of Lens Area Covered by Film Deposits at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.

5. Percentage of Lens Area Covered by Crystalline Deposits at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.

6. Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit [Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis

7. Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point.

8. Lens Wear Time at Each Visit Day [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Subject recorded a response to the question, "How many hours have you worn your contact lenses today?" Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point.

9. Average Rewetting Drop Frequency at Each Visit [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

   Subject recorded a response to the question, "Averaging over the last 3 days, how many times per day did you use rewetting drops?" Habitual lenses were used at the Day 0 time point.

10. Number of Unscheduled Lens Replacements by Reason [Up to Day 180]

    Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point.

11. Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

    Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.

12. Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

    Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.

13. Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." [Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180]

    Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;

• Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the investigational products or affect the results of this study;

• Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);

• History of intolerance or hypersensitivity to any component of the investigational products;

• Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;

• Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;

• Corneal vascularization that is mild (grade 2) or higher;

• Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;

• Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;

• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;

• Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;

• Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);

• Participation in any investigational clinical study within 30 days of Visit 1;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Japan, Ltd. for Trial Locations	Tokyo		Japan	105-6333

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Group Manager, Clinical Development, Alcon Japan, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02771145
• Other Study ID Numbers: LCE293-C001
• First Posted: May 12, 2016
• Last Update Posted: Jan 10, 2019
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Refractive Errors; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 6 study centers located in Japan.
Pre-assignment Detail	Of the 91 enrolled, 1 subject was exited as a screen failure prior to treatment. This reporting group includes all treated subjects (90).

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Period Title: Overall Study
STARTED	90
COMPLETED	86
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Overall Participants	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.1 (9.05)
Sex: Female, Male (Count of Participants)
Female	69 76.7%
Male	21 23.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Eyes With Visibly Clean Lenses at Each Visit
Description	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. Both eyes contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with non-missing response

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Measure Eyes	180
Day 7	92.2
Day 30	88.2
Day 60	95.5
Day 90	92.5
Day 135	95.2
Day 180	95.9

2. Primary Outcome

Title	Number of Eyes With Film Deposits on Lens by Type at Each Visit
Description	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Type II	Type III	Type IV
Arm/Group Description	Films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification	Films or deposits readily visible on a dry lens under room lighting, with unaided eye	Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
Measure Participants	90	90	90
Measure Eyes	180	180	180
Day 7	0	3	1
Day 30	3	0	4
Day 60	1	0	3
Day 90	1	1	2
Day 135	2	1	2
Day 180	1	0	1

3. Primary Outcome

Title	Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Description	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Type II	Type III	Type IV
Arm/Group Description	Films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification	Films or deposits readily visible on a dry lens under room lighting, with unaided eye	Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
Measure Participants	90	90	90
Measure Eyes	180	180	180
Day 7	4	8	2
Day 30	5	4	8
Day 60	0	0	4
Day 90	1	0	10
Day 135	0	0	3
Day 180	0	0	5

4. Primary Outcome

Title	Percentage of Lens Area Covered by Film Deposits at Each Visit
Description	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Measure eyes	180
Day 7	7.5 (2.89)
Day 30	28.6 (14.92)
Day 60	17.5 (15.00)
Day 90	15.0 (10.00)
Day 135	6.0 (2.24)
Day 180	7.5 (3.54)

5. Primary Outcome

Title	Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Description	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Measure Eyes	180
Day 7	10.4 (7.90)
Day 30	10.8 (9.65)
Day 60	8.8 (2.50)
Day 90	7.1 (3.45)
Day 135	11.7 (7.64)
Day 180	13.0 (9.75)

6. Primary Outcome

Title	Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Description	Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis
Time Frame	Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with non-missing response

Arm/Group Title	≥3 Line Increase	2 Line Increase	1 Line Increase	No Change	1 Line Decrease	2 Line Decrease	≥3 Line Decrease
Arm/Group Description
Measure Participants	90	90	90	90	90	90	90
Measure Eyes	180	180	180	180	180	180	180
Day 7	0.6	0.6	6.2	90.4	1.7	0.6	0.0
Day 30	1.7	3.4	7.3	84.8	2.8	0.0	0.0
Day 60	1.7	3.4	10.7	79.2	3.9	1.1	0.0
Day 90	0.0	3.4	11.5	79.9	4.6	0.6	0.0
Day 135	1.8	3.0	8.3	77.4	8.9	0.6	0.0
Day 180	1.2	2.3	9.9	75.6	8.1	1.7	1.2

7. Primary Outcome

Title	Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Description	Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with non-missing response

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Day 0	12.4 (2.54)
Day 7	11.9 (2.58)
Day 30	12.0 (2.50)
Day 60	11.8 (2.53)
Day 90	11.7 (2.73)
Day 135	11.9 (2.78)
Day 180	11.8 (2.57)

8. Primary Outcome

Title	Lens Wear Time at Each Visit Day
Description	Subject recorded a response to the question, "How many hours have you worn your contact lenses today?" Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with non-missing response

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Day 0	4.3 (3.53)
Day 7	4.8 (3.53)
Day 30	4.7 (3.27)
Day 60	4.2 (3.04)
Day 90	4.4 (3.33)
Day 135	4.4 (3.28)
Day 180	4.6 (3.35)

9. Primary Outcome

Title	Average Rewetting Drop Frequency at Each Visit
Description	Subject recorded a response to the question, "Averaging over the last 3 days, how many times per day did you use rewetting drops?" Habitual lenses were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with non-missing response

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Day 0	0.3 (1.11)
Day 7	1.4 (2.27)
Day 30	1.7 (1.85)
Day 60	1.6 (1.79)
Day 90	1.7 (1.93)
Day 135	1.8 (1.97)
Day 180	1.7 (2.00)

10. Primary Outcome

Title	Number of Unscheduled Lens Replacements by Reason
Description	Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point.
Time Frame	Up to Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set, with specified reason for replacement.

Arm/Group Title	FID 120947A
Arm/Group Description	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
Measure Participants	90
Unplanned - Lens torn on eye	5
Unplanned - Lens torn while handling	38
Unplanned - Lens deposit	17
Unplanned - Bad edge	4
Unplanned - Bad surface	0
Unplanned - Discoloration	0
Unplanned - No lens in pack	0
Unplanned - Visual Acuity	2
Unplanned - Discomfort	6
Unplanned - Pathology	0
Unplanned - Lost	7
Other	2

11. Primary Outcome

Title	Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Description	Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Strongly Agree	Agree	Undecided	Disagree	Strongly Disagree
Arm/Group Description
Measure Participants	90	90	90	90	90
Day 0	26.7	44.4	22.2	6.7	0.0
Day 7	35.6	41.1	15.6	7.8	0.0
Day 30	29.2	48.3	13.5	9.0	0.0
Day 60	34.8	46.1	14.6	4.5	0.0
Day 90	36.0	49.4	11.2	2.2	1.1
Day 135	38.8	44.7	16.5	0.0	0.0
Day 180	41.9	50.0	8.1	0.0	0.0

12. Primary Outcome

Title	Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Description	Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set with non-missing response

Arm/Group Title	Strongly Agree	Agree	Undecided	Disagree	Strongly Disagree
Arm/Group Description
Measure Participants	90	90	90	90	90
Day 0	42.2	38.9	12.2	5.6	1.1
Day 7	48.9	37.8	10.0	3.3	0.0
Day 30	46.1	37.1	14.6	2.2	0.0
Day 60	42.7	41.6	13.5	2.2	0.0
Day 90	39.3	47.2	13.5	0.0	0.0
Day 135	41.2	47.1	10.6	0.0	1.2
Day 180	44.2	48.8	7.0	0.0	0.0

13. Primary Outcome

Title	Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Description	Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Time Frame	Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180

Outcome Measure Data

Analysis Population Description

Full Analysis Set with non-missing response

Arm/Group Title	Strongly Agree	Agree	Undecided	Disagree	Strongly Disagree
Arm/Group Description
Measure Participants	90	90	90	90	90
Day 0	44.4	41.1	12.2	2.2	0.0
Day 7	28.9	32.2	25.6	12.2	1.1
Day 30	31.5	39.3	19.1	7.9	2.2
Day 60	25.8	40.4	27.0	5.6	1.1
Day 90	30.3	41.6	22.5	3.4	2.2
Day 135	29.4	44.7	21.2	2.4	2.4
Day 180	34.9	40.7	19.8	2.3	2.3

Adverse Events

Time Frame	Day 1 through study completion, an average of 6 months
Adverse Event Reporting Description	An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Arm/Group Title	FID 120977A - Subject Based Adverse Events		FID 120977A - Ocular Adverse Events
Arm/Group Description	All subjects treated with FID 120947A contact lens disinfecting solution		All eyes treated with FID 120947A contact lens disinfecting solution
All Cause Mortality
	FID 120977A - Subject Based Adverse Events		FID 120977A - Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/180 (0%)
Serious Adverse Events
	FID 120977A - Subject Based Adverse Events		FID 120977A - Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/180 (0%)
Other (Not Including Serious) Adverse Events
	FID 120977A - Subject Based Adverse Events		FID 120977A - Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		25/180 (13.9%)
Eye disorders
Eye irritation	0/90 (0%)		11/180 (6.1%)
Vision blurred	0/90 (0%)		18/180 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.