Refractive ErrorNCT02771145
Clinical Evaluation of the Safety and Efficacy of FID 120947A
A study testing FID 120947A contact lens disinfecting solution, Soft contact lenses (SCL) and SCL preservative solution in people with Refractive Error, run by Alcon Research at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- FID 120947A contact lens disinfecting solution, Soft contact lenses (SCL) and SCL preservative solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteJapan
- Study dates
- 20 May 2016to 10 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
- Conditions
- Refractive Error
- Being tested
- FID 120947A contact lens disinfecting solution, Soft contact lenses (SCL), SCL preservative solution
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 120947A contact lens disinfecting solutionDevice
Also called Clear Care® Plus
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
Soft contact lenses (SCL)Device
Also called 2-Week Acuvue®
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.
SCL preservative solutionDevice
Commercially available solution for rinsing soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| FID 120947A | Experimental | 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. Receives: Device: FID 120947A contact lens disinfecting solution; Device: Soft contact lenses (SCL); Device: SCL preservative solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Measured: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Up to Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Measured: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start20 May 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Group Manager, Clinical Development, Study director, Alcon Japan, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771145
- Sponsor's protocol ID
- LCE293-C001
- Status last verified
- Oct 2018
- First submitted
- 11 May 2016
- Last updated
- 10 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of FID 120947A
- ClinicalTrials.gov ID
- NCT02771145
- Acronym / sponsor ID
- LCE293-C001
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 May 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 15 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FID 120947A | Experimental | Device: FID 120947A contact lens disinfecting solution, Device: Soft contact lenses (SCL), Device: SCL preservative solutionFID 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID 120947A contact lens disinfecting solutionAlso: Clear Care® PlusInvestigational 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 | Device | FID 120947A |
| Soft contact lenses (SCL)Also: 2-Week Acuvue®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. | Device | FID 120947A |
| SCL preservative solutionCommercially available solution for rinsing soft contact lenses | Device | FID 120947A |
Primary outcome
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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
Time frame: Up to Day 180
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."
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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."
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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."
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Group Manager, Clinical Development study director
Alcon Japan, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID 120947A contact lens disinfecting solution, Soft contact lenses (SCL) and SCL preservative solution in people with Refractive Error, run by Alcon Research at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eyes With Visibly Clean Lenses at Each Visit (time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.