Back to resultsClinical Evaluation of the Safety and Efficacy of FID 120947A
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
FID 120947A contact lens disinfecting solution
Soft contact lenses (SCL)
SCL preservative solution
Sponsored by
About this trial
This is an interventional supportive care trial for Refractive Error
Eligibility Criteria
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.
Sites / Locations
- Contact Alcon Japan, Ltd. for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FID 120947A
Arm 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.
Outcomes
Primary Outcome Measures
Percentage of Eyes With Visibly Clean Lenses at Each Visit
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.
Number of Eyes With Film Deposits on Lens by Type at Each Visit
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.
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
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.
Percentage of Lens Area Covered by Film Deposits at Each Visit
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.
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
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.
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
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
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
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.
Lens Wear Time at Each Visit Day
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.
Average Rewetting Drop Frequency at Each Visit
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.
Number of Unscheduled Lens Replacements by Reason
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.
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
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.
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
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.
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02771145
Brief Title
Clinical Evaluation of the Safety and Efficacy of FID 120947A
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 20, 2016 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
January 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FID 120947A
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
FID 120947A contact lens disinfecting solution
Other Intervention Name(s)
Clear Care® Plus
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Soft contact lenses (SCL)
Other Intervention Name(s)
2-Week Acuvue®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SCL preservative solution
Intervention Description
Commercially available solution for rinsing soft contact lenses
Primary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Group Manager, Clinical Development
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Japan, Ltd. for Trial Locations
City
Tokyo
ZIP/Postal Code
105-6333
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Safety and Efficacy of FID 120947A
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