Back to resultsSafety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Primary Purpose
Myopia, Astigmatism, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 120947A contact lens disinfecting solution
renu fresh multi-purpose solution
Soft contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia focused on measuring contact lenses, contact lens solution, soft contact lenses
Eligibility Criteria
Inclusion Criteria:
- Normal eyes (other than correction for visual acuity);
- Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FID 120947A
renu fresh
Arm Description
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
Outcomes
Primary Outcome Measures
Percentage of Subjects With Visibly Clean Lenses
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.
Percentage of Subjects With Crystalline Deposits by Type
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.
Percentage of Subjects With Film Deposits by Type
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.
Average Residual Lens Lysozyme
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.
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
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.
Average Lens Wear Time
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.
Number of Unscheduled Lens Replacements by Reason
A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. 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.
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.
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.
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.
Crystalline Deposit Area Covered
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.
Film Deposit Area Covered
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01912768
Brief Title
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Official Title
Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (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 demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.
Detailed Description
Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism, Hyperopia, Refractive Error
Keywords
contact lenses, contact lens solution, soft contact lenses
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
362 (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 90 days
Arm Title
renu fresh
Arm Type
Active Comparator
Arm Description
Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
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 intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
Intervention Type
Device
Intervention Name(s)
renu fresh multi-purpose solution
Intervention Description
Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
Intervention Type
Device
Intervention Name(s)
Soft contact lenses
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 (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.
Primary Outcome Measure Information:
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
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
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
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 30/Early Exit
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
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
Title
Number of Unscheduled Lens Replacements by Reason
Description
A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. 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.
Time Frame
Up to Day 90
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
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
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
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
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Normal eyes (other than correction for visual acuity);
Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Studzinski, Lead CSM
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
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