Contact Lens WettabilityNCT01342107
Effect of FID 114675A on Lens Wettability
A study testing FID 114675A multi-purpose disinfecting solution (MPDS), Soft contact lens and Blister pack solution in people with Contact Lens Wettability, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wettability
- What is being tested?
- FID 114675A multi-purpose disinfecting solution (MPDS), Soft contact lens and Blister pack solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 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 or age or older with normal eyes, other than correction for refractive error.
- At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
- Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
- Other protocol-defined 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 test articles or affect the results of the study.
- 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 or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Participation in any investigational study within the past 30 days.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76314
About this study
Official title: The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
- Conditions
- Contact Lens Wettability
- Being tested
- FID 114675A multi-purpose disinfecting solution (MPDS), Soft contact lens, Blister pack solution
- Keywords
- Contact Lenses, Contact Lens Care, Multi-Purpose Solution Wettability, 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
Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
Soft contact lensDevice
Also called Acuvue2, PureVision, Acuvue Oasys
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
Blister pack solutionDevice
Also called Acuvue2, PureVision, Acuvue Oasys
Commercially approved storage solution as found in the contact lens blister pack.
| Study group | Role | What they receive |
|---|---|---|
| FID 114675A | Experimental | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. Receives: Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: Soft contact lens |
| Blister Pack | Active comparator | Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. Receives: Device: Soft contact lens; Device: Blister pack solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Wettability
As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startDec 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 WettabilityStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT01342107
- Sponsor's protocol ID
- C-10-024
- Status last verified
- Mar 2012
- First submitted
- 7 Jan 2011
- Last updated
- 13 Apr 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 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability
- ClinicalTrials.gov ID
- NCT01342107
- Acronym / sponsor ID
- C-10-024
- Conditions
- Contact Lens Wettability
- Keywords
- Contact Lenses, Contact Lens Care, Multi-Purpose Solution Wettability, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 13 Apr 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 lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 114675A | Experimental | Device: FID 114675A multi-purpose disinfecting solution (MPDS), Device: Soft contact lensContact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
| Blister Pack | Active comparator | Device: Soft contact lens, Device: Blister pack solutionContact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
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 or age or older with normal eyes, other than correction for refractive error.
- At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
- Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
- 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 or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
- History or current ocular infections or ocular inflammatory events.
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)Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses. | Device | FID 114675A |
| Soft contact lensAlso: Acuvue2, PureVision, Acuvue OasysSoft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense. | Device | Blister Pack, FID 114675A |
| Blister pack solutionAlso: Acuvue2, PureVision, Acuvue OasysCommercially approved storage solution as found in the contact lens blister pack. | Device | Blister Pack |
Primary outcome
Lens Wettability
Time frame: 16 hours
As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
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 114675A multi-purpose disinfecting solution (MPDS), Soft contact lens and Blister pack solution in people with Contact Lens Wettability, run by Alcon Research at 1 site in United States.
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 8 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 13 Apr 2012. 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 United States. 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 13 Apr 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 Wettability (time frame: 16 hours). 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 13 Apr 2012.