Contact Lens FitNCT01240135
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
A study testing FID 114675A multi-purpose disinfecting solution (MPDS), renu fresh Multi-Purpose Solution (MPS) and Galyfilcon A contact lenses (Acuvue Advance) in people with Contact Lens Fit and Myopia, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Fit, Myopia
- What is being tested?
- FID 114675A multi-purpose disinfecting solution (MPDS), renu fresh Multi-Purpose Solution (MPS) and Galyfilcon A contact lenses (Acuvue Advance)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Feb 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
- Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
- History of intolerance or known sensitivity to any component of the treatments.
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
- Conditions
- Contact Lens Fit, Myopia
- Being tested
- FID 114675A multi-purpose disinfecting solution (MPDS), renu fresh Multi-Purpose Solution (MPS), Galyfilcon A contact lenses (Acuvue Advance)
- Keywords
- Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 114675A multi-purpose disinfecting solution (MPDS)Device
Also called Alcon Multi-Purpose Disinfecting Solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
renu fresh Multi-Purpose Solution (MPS)Device
Also called Bausch + Lomb renu® fresh™ Multi-Purpose Solution
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Galyfilcon A contact lenses (Acuvue Advance)Device
Also called Acuvue® Advance®
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
| Study group | Role | What they receive |
|---|---|---|
| FID 114576A / renu fresh | Other | FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. Receives: Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Galyfilcon A contact lenses (Acuvue Advance) |
| renu fresh / FID 114675A | Other | Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. Receives: Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Galyfilcon A contact lenses (Acuvue Advance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Fit
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Measured: Day 14 of lens wear
Secondary outcomes (1)
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
Measured: Day 14 of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 Contact Lens FitStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240135
- Sponsor's protocol ID
- C-10-030
- Status last verified
- Jun 2012
- First submitted
- 10 Nov 2010
- Last updated
- 12 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
- ClinicalTrials.gov ID
- NCT01240135
- Acronym / sponsor ID
- C-10-030
- Conditions
- Contact Lens Fit, Myopia
- Keywords
- Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Posted 12 Jul 2012
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 clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 114576A / renu fresh | Other | Device: FID 114675A multi-purpose disinfecting solution (MPDS), Device: renu fresh Multi-Purpose Solution (MPS), Device: Galyfilcon A contact lenses (Acuvue Advance)FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. |
| renu fresh / FID 114675A | Other | Device: FID 114675A multi-purpose disinfecting solution (MPDS), Device: renu fresh Multi-Purpose Solution (MPS), Device: Galyfilcon A contact lenses (Acuvue Advance)Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
- Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
- History of intolerance or known sensitivity to any component of the treatments.
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
- Other protocol-defined exclusion criteria may apply.
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 114675A multi-purpose disinfecting solution (MPDS)Also: Alcon Multi-Purpose Disinfecting Solution (MPDS)Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours. | Device | FID 114576A / renu fresh, renu fresh / FID 114675A |
| renu fresh Multi-Purpose Solution (MPS)Also: Bausch + Lomb renu® fresh™ Multi-Purpose SolutionDaily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours. | Device | FID 114576A / renu fresh, renu fresh / FID 114675A |
| Galyfilcon A contact lenses (Acuvue Advance)Also: Acuvue® Advance®A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days. | Device | FID 114576A / renu fresh, renu fresh / FID 114675A |
Primary outcome
Lens Fit
Time frame: Day 14 of lens wear
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
1 secondary outcome
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
Time frame: Day 14 of lens wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Contact Lens Fit
Enrolling by invitation
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
Healthy Participants Study, Contact Lens Wear
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FID 114675A multi-purpose disinfecting solution (MPDS), renu fresh Multi-Purpose Solution (MPS) and Galyfilcon A contact lenses (Acuvue Advance) in people with Contact Lens Fit and Myopia, run by Alcon Research.
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 5 inclusion and 5 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 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 12 Jul 2012). 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?
Lens Fit (time frame: Day 14 of lens wear). 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 12 Jul 2012.