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

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ClinicalTrials.gov Identifier: NCT01912781
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Conditions Myopia
Astigmatism
Hyperopia
Refractive Error
Interventions Device: FID 120947A contact lens disinfecting solution
Device: Boston Simplus multi-action solution
Device: Gas permeable contact lenses
Enrollment 112
Recruitment Details Subjects were recruited from 12 study centers located in the US.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title FID 120974A Boston Simplus Total
Hide 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 Number of Baseline Participants 71 35 106
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 35 participants 106 participants
52.9  (10.2) 50.5  (13.4) 52.1  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 35 participants 106 participants
Female
55
  77.5%
28
  80.0%
83
  78.3%
Male
16
  22.5%
7
  20.0%
23
  21.7%
1.Primary Outcome
Title Percentage of Subjects With Visibly Clean Lenses
Hide 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
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Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 71 35
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 71 35
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
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Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 71 35
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
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Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Mean (Standard Deviation)
Unit of Measure: Hours
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
Hide 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
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Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 71 35
Measure Type: Number
Unit of Measure: lenses
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."
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of subjects
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."
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of subjects
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."
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with data at visit.
Arm/Group Title FID 120974A Boston Simplus
Hide 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
Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 71 35
Mean (Standard Deviation)
Unit of Measure: percentage of lens area
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 71 35
Mean (Standard Deviation)
Unit of Measure: percentage of lens area
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)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pre-treatment FID 120974A Boston Simplus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   0/71 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-treatment FID 120974A Boston Simplus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   0/71 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Lead, GCRA
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01912781     History of Changes
Other Study ID Numbers: C-13-004
First Submitted: July 29, 2013
First Posted: July 31, 2013
Results First Submitted: May 26, 2015
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015