Healthy Contact Lens WearersNCT01341977
Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution
A study testing Alcon MPDS and ReNu Fresh MPS in people with Healthy Contact Lens Wearers, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Contact Lens Wearers
- What is being tested?
- Alcon MPDS and ReNu Fresh MPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
- Patient must be able to read.
- Vision correctable to 20/30 or better with contact lenses.
Who cannot join
- Sensitivity to multi-purpose solutions.
- Using any topical ocular OTC or prescribed topical ocular medications.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- With a medical condition or using medications that cause ocular side effects.
- Participation in any investigational study within the past 30 days.
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: Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)
The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
Read the detailed description
The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
- Conditions
- Healthy Contact Lens Wearers
- Being tested
- Alcon MPDS, ReNu Fresh MPS
- 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.
Alcon MPDSDevice
Also called Alcon Multi-Purpose Disinfecting Solution (MPDS)
Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses
ReNu Fresh MPSDevice
Also called ReNu Fresh Multi-Purpose Solution (MPS)
ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Alcon MPDS | Experimental | Alcon Multi-Purpose Disinfecting Solution (MPDS) Receives: Device: Alcon MPDS |
| ReNu Fresh Multi-Purpose Solution | Active comparator | ReNu Fresh Multi-Purpose Solution Receives: Device: ReNu Fresh MPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Acceptance
Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Measured: Day 90
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 completionMay 2010
- Study completionMay 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 Healthy Contact Lens WearersStudies 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
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessie M Lemp, MS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341977
- Sponsor's protocol ID
- C-09-026
- Status last verified
- Sep 2011
- First submitted
- 9 Dec 2009
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)
- ClinicalTrials.gov ID
- NCT01341977
- Acronym / sponsor ID
- C-09-026
- Conditions
- Healthy Contact Lens Wearers
- Keywords
- Contact Lenses, Contact Lens Care, Multi-Purpose Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Apr 2011 (estimated)
- Results
- Posted 13 Oct 2011
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 determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
Detailed description
The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
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 |
|---|---|---|
| Alcon MPDS | Experimental | Device: Alcon MPDSAlcon Multi-Purpose Disinfecting Solution (MPDS) |
| ReNu Fresh Multi-Purpose Solution | Active comparator | Device: ReNu Fresh MPSReNu Fresh Multi-Purpose Solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
- Patient must be able to read.
- Vision correctable to 20/30 or better with contact lenses.
Key exclusion criteria (6 listed)
- Sensitivity to multi-purpose solutions.
- Using any topical ocular OTC or prescribed topical ocular medications.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- With a medical condition or using medications 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 |
|---|---|---|
| Alcon MPDSAlso: Alcon Multi-Purpose Disinfecting Solution (MPDS)Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses | Device | Alcon MPDS |
| ReNu Fresh MPSAlso: ReNu Fresh Multi-Purpose Solution (MPS)ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses. | Device | ReNu Fresh Multi-Purpose Solution |
Primary outcome
Subjective Acceptance
Time frame: Day 90
Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- 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.
Jessie M Lemp, MS 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 Alcon MPDS and ReNu Fresh MPS in people with Healthy Contact Lens Wearers, 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 3 inclusion and 6 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 23 Sep 2020. 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 Oct 2011). 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?
Subjective Acceptance (time frame: Day 90). 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 23 Sep 2020.