Contact Lens MoistureNCT01341990
Effect of an Investigational Multi-Purpose Solution on Lens Moisture
A study testing FID 114675A Multi-Purpose Disinfecting Solution (MPDS), ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) and Silicone Hydrogel Contact Lenses in people with Contact Lens Moisture, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Moisture
- What is being tested?
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) and Silicone Hydrogel Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2010
- 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.
- Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
- Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
- Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Known sensitivity or intolerance to contact lens multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medication that cause ocular side effects.
- 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, 76134
About this study
Official title: Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.
- Conditions
- Contact Lens Moisture
- Being tested
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS), Silicone Hydrogel Contact Lenses
- Keywords
- Contact Lenses, Contact Lens Care, Multi-Purpose Solution
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 solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses
ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)Device
Also called ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™
Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses
Silicone Hydrogel Contact LensesDevice
Also called Acuvue® Oasys™, PureVision®
Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).
| Study group | Role | What they receive |
|---|---|---|
| FID 114675A | Experimental | Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Receives: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Silicone Hydrogel Contact Lenses |
| ReNu MultiPlus | Active comparator | Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Receives: Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS); Device: Silicone Hydrogel Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ex-Vivo Advancing Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Measured: Day 1, 8 hours
Mean Ex-Vivo Advancing Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Measured: Day 8, 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
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 MoistureStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin R Webb, OD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341990
- Sponsor's protocol ID
- C-09-031
- Status last verified
- Mar 2012
- First submitted
- 9 Dec 2009
- 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
- Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture
- ClinicalTrials.gov ID
- NCT01341990
- Acronym / sponsor ID
- C-09-031
- Conditions
- Contact Lens Moisture
- Keywords
- Contact Lenses, Contact Lens Care, Multi-Purpose Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 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 the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 114675A | Experimental | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Device: Silicone Hydrogel Contact LensesMulti-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses |
| ReNu MultiPlus | Active comparator | Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS), Device: Silicone Hydrogel Contact LensesMulti-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses |
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.
- Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
- Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
- Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Known sensitivity or intolerance to contact lens multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medication that cause ocular side effects.
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 solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses | Device | FID 114675A |
| ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)Also: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses | Device | ReNu MultiPlus |
| Silicone Hydrogel Contact LensesAlso: Acuvue® Oasys™, PureVision®Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2). | Device | FID 114675A, ReNu MultiPlus |
Primary outcome
Mean Ex-Vivo Advancing Contact Angle
Time frame: Day 1, 8 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Mean Ex-Vivo Advancing Contact Angle
Time frame: Day 8, 16 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
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.
Justin R Webb, OD study director
Alcon Research
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), ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) and Silicone Hydrogel Contact Lenses in people with Contact Lens Moisture, 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 7 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?
Mean Ex-Vivo Advancing Contact Angle (time frame: Day 1, 8 hours). The study lists 2 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 13 Apr 2012.