Symptomatic Contact Lens WearersNCT01187355
Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers
A study testing FID 114675A Multi-Purpose Disinfecting Solution (MPDS), renu fresh Multi-Purpose Solution (MPS) and Contact lenses in people with Symptomatic Contact Lens Wearers, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Contact Lens Wearers
- What is being tested?
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), renu fresh Multi-Purpose Solution (MPS) and Contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 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
- Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
- Vision correctable to 20/30 or better with contact lenses.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Sensitivity to multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History (6 months) or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medications 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: SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
- Conditions
- Symptomatic Contact Lens Wearers
- Being tested
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), renu fresh Multi-Purpose Solution (MPS), Contact lenses
- Keywords
- Symptomatic, 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 multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.
renu fresh Multi-Purpose Solution (MPS)Device
Also called renu® fresh™ Multi-Purpose Solution
Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.
Contact lensesDevice
Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
| Study group | Role | What they receive |
|---|---|---|
| Alcon MPDS | Experimental | MPDS used for 30 days as specified in protocol for contact lens care. Receives: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Contact lenses |
| renu fresh MPS | Active comparator | MPS used for 30 days as indicated for contact lens care. Receives: Device: renu fresh Multi-Purpose Solution (MPS); Device: Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Measured: Day 30
Secondary outcomes (2)
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Measured: Day 30
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 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 Symptomatic Contact Lens WearersStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 591 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
- NCT01187355
- Sponsor's protocol ID
- C-09-074
- Status last verified
- Jun 2012
- First submitted
- 20 Aug 2010
- Last updated
- 30 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 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT01187355
- Acronym / sponsor ID
- C-09-074
- Conditions
- Symptomatic Contact Lens Wearers
- Keywords
- Symptomatic, Contact lens care, Multi-purpose solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Posted 30 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 compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcon MPDS | Experimental | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Device: Contact lensesMPDS used for 30 days as specified in protocol for contact lens care. |
| renu fresh MPS | Active comparator | Device: renu fresh Multi-Purpose Solution (MPS), Device: Contact lensesMPS used for 30 days as indicated for contact lens care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
- Vision correctable to 20/30 or better with contact lenses.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Sensitivity to multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History (6 months) or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of 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 |
|---|---|---|
| FID 114675A Multi-Purpose Disinfecting Solution (MPDS)Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days. | Device | Alcon MPDS |
| renu fresh Multi-Purpose Solution (MPS)Also: renu® fresh™ Multi-Purpose SolutionCommercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days. | Device | renu fresh MPS |
| Contact lensesContact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis. | Device | Alcon MPDS, renu fresh MPS |
Primary outcome
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
Time frame: Day 30
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
2 secondary outcomes
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
Time frame: Day 30
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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), renu fresh Multi-Purpose Solution (MPS) and Contact lenses in people with Symptomatic 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 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 30 Jul 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 30 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?
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. (time frame: Day 30). 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 30 Jul 2012.