- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912768
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
June 10, 2015 updated by: Alcon Research
Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
362
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FID 120947A
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
Other Names:
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.
|
Active Comparator: renu fresh
Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
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.
Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects With Visibly Clean Lenses
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Percentage of Subjects With Crystalline Deposits by Type
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Percentage of Subjects With Film Deposits by Type
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Average Residual Lens Lysozyme
Time Frame: Day 30/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.
|
Day 30/Early Exit
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Time Frame: 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.
|
Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
|
Average Lens Wear Time
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Number of Unscheduled Lens Replacements by Reason
Time Frame: Up to Day 90
|
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.
|
Up to Day 90
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Crystalline Deposit Area Covered
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Film Deposit Area Covered
Time Frame: 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.
|
Day 7, Day 30, Day 60, Day 90
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Monica Studzinski, Lead CSM, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
July 9, 2015
Last Update Submitted That Met QC Criteria
June 10, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-13-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractive Error
-
Alcon ResearchCompletedRefractive Error - Myopia Severe | Refractive Error - Myopia SimpleUnited States, Ireland, Singapore
-
Vision Service PlanCompletedRefractive Error - Myopia BilateralUnited States
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vision Service PlanCompletedRefractive Error - Myopia BilateralUnited States
-
Wang HongxiaTianjin Eye HospitalCompletedRefractive Error - Myopia AxialChina
-
Tianjin Eye HospitalRecruitingMyopia; Refractive ErrorChina
-
Abbott Medical OpticsCompletedStable Myopic Refractive Error, With or Without AstigmatismUnited States
-
KK Women's and Children's HospitalWithdrawnRefractive Error - Myopia
-
Alcon ResearchCompletedRefractive ErrorsUnited States
-
Alcon ResearchCompletedRefractive ErrorsUnited States
Clinical Trials on FID 120947A contact lens disinfecting solution
-
Alcon ResearchCompleted
-
Alcon ResearchCompletedRefractive Error | Astigmatism | Myopia | Hyperopia
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
Johnson & Johnson Vision Care, Inc.CompletedMyopiaUnited States, United Kingdom
-
Alcon ResearchCompleted
-
Alcon ResearchCompletedContact Lens MoistureUnited States
-
Alcon ResearchCompletedSymptomatic Contact Lens WearersUnited States
-
CIBA VISIONUniversity of WaterlooCompleted