Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01912781
• Collaborator: (none)
• Enrollment: 112
• Arms: 2
• Duration (Months): 5.9

Study Details

Study Description

Brief Summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Hyperopia; Refractive Error	Device: FID 120947A contact lens disinfecting solution; Device: Boston Simplus multi-action solution; Device: Gas permeable contact lenses	N/A

Detailed Description

Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution in Gas Permeable Contact Lens Wearers
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FID 120974A FID 120947A contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Device: FID 120947A contact lens disinfecting solution; Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses; Other Names: Clear Care® Plus ; Device: Gas permeable contact lenses; Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).; Other Names: Boston XO Boston II
Active Comparator: Boston Simplus Boston Simplus multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Device: Boston Simplus multi-action solution; Commercially available solution indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses; Device: Gas permeable contact lenses; Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).; Other Names: Boston XO Boston II

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Visibly Clean Lenses [Day 7, Day 30, Day 60, Day 90]

   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. One eye (study eye) contributed to the analysis.

2. Percentage of Subjects With Crystalline Deposits by Type [Day 7, Day 30, Day 60, Day 90]

   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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.

3. Percentage of Subjects With Film Deposits by Type [Day 7, Day 30, Day 60, Day 90]

   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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.

4. Average Residual Lens Lysozyme [Day 90/Early Exit]

   Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.

5. Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change [Baseline (Day 0), Day 7, Day 30, Day 60, Day 90]

   Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.

6. Average Lens Wear Time [Day 7, Day 30, Day 60, Day 90]

   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 measured in hours.

7. Number of Unscheduled Lens Replacements by Reason [Up to Day 90]

   No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.

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

   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.

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

   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.

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

    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.

11. Crystalline Deposit Area Covered [Day 7, Day 30, Day 60, Day 90]

    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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.

12. Film Deposit Area Covered [Day 7, Day 30, Day 60, Day 90]

    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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Normal eyes (other than correction for visual acuity);

• Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;

• Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;

• Other protocol-defined 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;

• Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;

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

• Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;

• Moderate, severe, abnormal, or other ocular findings;

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

• Any systemic disease at Visit 1 (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;

• Ocular surgery within the last 12 months;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Lieve Convents, Lead CSM, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01912781
• Other Study ID Numbers: C-13-004
• First Posted: Jul 31, 2013
• Last Update Posted: Jun 30, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Alcon Research: contact lenses; contact lens solution; gas permeable contact lenses
• Additional relevant MeSH terms: Astigmatism; Refractive Errors; Hyperopia; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 12 study centers located in the US.
Pre-assignment Detail	Of the 112 enrolled, 2 subjects were exited as screen failures and 4 were discontinued prior to randomization. This reporting group includes all randomized subjects (106).

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Period Title: Overall Study
STARTED	71	35
COMPLETED	69	35
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	FID 120974A	Boston Simplus	Total
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Total of all reporting groups
Overall Participants	71	35	106
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.9 (10.2)	50.5 (13.4)	52.1 (11.4)
Sex: Female, Male (Count of Participants)
Female	55 77.5%	28 80%	83 78.3%
Male	16 22.5%	7 20%	23 21.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Visibly Clean Lenses
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. One eye (study eye) contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7	42.0	57.1
Day 30	29.0	42.9
Day 60	29.0	42.9
Day 90	30.4	31.4

2. Primary Outcome

Title	Percentage of Subjects With Crystalline Deposits by Type
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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Day 7, Type II, n=10, 5	90.0	80.0
Day 7, Type III, n=10, 5	0.0	20.0
Day 7, Type IV, n=10, 5	10.0	0.0
Day 30, Type II, n=17, 3	70.6	100.0
Day 30, Type III, n=17, 3	17.6	0.0
Day 30, Type IV, n=17, 3	11.8	0.0
Day 60, Type II, n=18, 8	61.1	87.5
Day 60, Type III, n=18, 8	16.7	0.0
Day 60, Type IV, n=18, 8	22.2	12.5
Day 90, Type II, n=21, 10	61.9	60.0
Day 90, Type III, n=21, 10	23.8	10.0
Day 90, Type IV, n=21, 10	14.3	30.0

3. Primary Outcome

Title	Percentage of Subjects With Film Deposits by Type
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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Day 7, Type II, n=40, 15	80.0	66.7
Day 7, Type III, n=40, 15	7.5	26.7
Day 7, Type IV, n=40, 15	12.5	6.7
Day 30, Type II, n=47, 20	72.3	80.0
Day 30, Type III, n=47, 20	10.6	10.0
Day 30, Type IV, n=47, 20	17.0	10.0
Day 60, Type II, n=47, 20	74.5	80.0
Day 60, Type III, n=47, 20	21.3	5.0
Day 60, Type IV, n=47, 20	4.3	15.0
Day 90, Type II, n=45, 24	73.3	79.2
Day 90, Type III, n=45, 24	13.3	8.3
Day 90, Type IV, n=45, 24	13.3	12.5

4. Primary Outcome

Title	Average Residual Lens Lysozyme
Description	Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Time Frame	Day 90/Early Exit

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Mean (Standard Deviation) [micrograms per lens]	0.2 (0.5)	0.2 (0.4)

5. Primary Outcome

Title	Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
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 a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Time Frame	Baseline (Day 0), Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7, 2 Line Increase from Baseline	0.0	0.0
Day 7, 1 Line Increase from Baseline	2.9	0.0
Day 7, No Change from Baseline	92.8	94.3
Day 7, 1 Line Decrease from Baseline	4.3	5.7
Day 7, 2 Line Decrease from Baseline	0.0	0.0
Day 30, 2 Line Increase from Baseline	0.0	0.0
Day 30, 1 Line Increase from Baseline	1.4	0.0
Day 30, No Change from Baseline	95.7	97.1
Day 30, 1 Line Decrease from Baseline	2.9	2.9
Day 30, 2 Line Decrease from Baseline	0.0	0.0
Day 60, 2 Line Increase from Baseline	1.4	0.0
Day 60, 1 Line Increase from Baseline	1.4	2.9
Day 60, No Change from Baseline	97.1	94.3
Day 60, 1 Line Decrease from Baseline	0.0	2.9
Day 60, 2 Line Decrease from Baseline	0.0	0.0
Day 90, 2 Line Increase from Baseline	0.0	2.9
Day 90, 1 Line Increase from Baseline	0.0	2.9
Day 90, No Change from Baseline	97.1	91.4
Day 90, 1 Line Decrease from Baseline	2.9	2.9
Day 90, 2 Line Decrease from Baseline	0.0	0.0

6. Primary Outcome

Title	Average Lens Wear Time
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 measured in hours.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7	12.3 (2.7)	13.3 (2.4)
Day 30	12.5 (2.7)	12.7 (2.8)
Day 60	11.8 (2.9)	13.3 (2.6)
Day 90	12.4 (2.8)	13.1 (2.6)

7. Primary Outcome

Title	Number of Unscheduled Lens Replacements by Reason
Description	No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Lost	3	1
Lens torn on eye	0	1
Lens torn while handling	1	0

8. 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.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7, Strongly Agree	30.4	68.6
Day 7, Agree	52.2	28.6
Day 7, Undecided	7.2	0.0
Day 7, Disagree	10.1	2.9
Day 7, Strongly Disgree	0.0	0.0
Day 30, Strongly Agree	31.9	68.6
Day 30, Agree	47.8	28.6
Day 30, Undecided	4.3	2.9
Day 30, Disagree	13.0	0.0
Day 30, Strongly Disagree	2.9	0.0
Day 60, Strongly Agree	30.4	62.9
Day 60, Agree	49.3	28.6
Day 60, Undecided	8.7	0.0
Day 60, Disagree	10.1	5.7
Day 60, Strongly Disagree	1.4	2.9
Day 90, Strongly Agree	30.4	54.3
Day 90, Agree	50.7	28.6
Day 90, Undecided	1.4	2.9
Day 90, Disagree	15.9	11.4
Day 90, Strongly Disagree	1.4	2.9

9. 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.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7, Strongly Agree	37.7	48.6
Day 7, Agree	40.6	45.7
Day 7, Undecided	2.9	0.0
Day 7, Disagree	15.9	5.7
Day 7, Strongly Disagree	2.9	0.0
Day 30, Strongly Agree	29.0	48.6
Day 30, Agree	53.6	45.7
Day 30, Undecided	7.2	2.9
Day 30, Disagree	10.1	2.9
Day 30, Strongly Disagree	0.0	0.0
Day 60, Strongly Agree	33.3	57.1
Day 60, Agree	49.3	28.6
Day 60, Undecided	4.3	5.7
Day 60, Disagree	11.6	8.6
Day 60, Strongly Disagree	1.4	0.0
Day 90, Strongly Agree	29.0	45.7
Day 90, Agree	49.3	34.3
Day 90, Undecided	7.2	5.7
Day 90, Disagree	13.0	14.3
Day 90, Strongly Disagree	1.4	0.0

10. 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.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects with data at visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	69	35
Day 7, Strongly Agree	23.2	48.6
Day 7, Agree	50.7	40.0
Day 7, Undecided	20.3	8.6
Day 7, Disagree	5.8	2.9
Day 7, Strongly Disagree	0.0	0.0
Day 30, Strongly Agree	26.1	57.1
Day 30, Agree	53.6	34.3
Day 30, Undecided	13.0	8.6
Day 30, Disagree	5.8	0.0
Day 30, Strongly Disagree	1.4	0.0
Day 60, Strongly Agree	26.1	51.4
Day 60, Agree	56.5	34.3
Day 60, Undecided	14.5	11.4
Day 60, Disagree	2.9	0.0
Day 60, Strongly Disagree	0.0	2.9
Day 90, Strongly Agree	27.5	48.6
Day 90, Agree	52.2	40.0
Day 90, Undecided	11.6	5.7
Day 90, Disagree	7.2	2.9
Day 90, Strongly Disagree	1.4	2.9

11. Primary Outcome

Title	Crystalline Deposit Area Covered
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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Day 7, n=10, 5	18.0 (16.2)	19.0 (18.2)
Day 30, n=17, 3	13.6 (18.1)	16.7 (20.2)
Day 60, n=18, 8	11.9 (14.1)	7.0 (3.5)
Day 90, n=21, 10	18.1 (16.3)	10.8 (14.5)

12. Primary Outcome

Title	Film Deposit Area Covered
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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Time Frame	Day 7, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.

Arm/Group Title	FID 120974A	Boston Simplus
Arm/Group Description	Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days	Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Measure Participants	71	35
Day 7, n=40, 15	23.8 (17.2)	22.7 (13.7)
Day 30, n=47, 20	26.2 (22.0)	28.4 (21.1)
Day 60, n=47, 20	26.4 (17.5)	24.0 (11.0)
Day 90, n=45, 24	25.3 (13.7)	28.3 (21.9)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (Nov 2013 - May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
Adverse Event Reporting Description	AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device or control product. AEs are reported as pre-treatment and treatment-emergent.
Arm/Group Title	Pre-treatment		FID 120974A		Boston Simplus
Arm/Group Description	All subjects who consented to participate in the study prior to exposure to investigational product		All subjects who were exposed to FID 120947A		All subjects who were exposed to Boston Simplus
All Cause Mortality
	Pre-treatment		FID 120974A		Boston Simplus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-treatment		FID 120974A		Boston Simplus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/71 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		FID 120974A		Boston Simplus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/71 (0%)		0/35 (0%)

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.