Contact Lens WearNCT00724269
Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium
A study testing OPTI-FREE RepleniSH and ReNu MultiPlus MPS in people with Contact Lens Wear, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- OPTI-FREE RepleniSH and ReNu MultiPlus MPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Successful contact lens wear on a daily wear basis
- Wear contact lenses at least 8 hours/day
- Vision correctable to at least 20/30
- Normal Eyes
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Topical ocular medication use
- Other protocol-defined inclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.
- Conditions
- Contact Lens Wear
- Being tested
- OPTI-FREE RepleniSH, ReNu MultiPlus MPS
- Keywords
- Contact lens wear, multi-purpose solution, corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTI-FREE RepleniSHDevice
Multi-Purpose Solution for soft contact lenses
ReNu MultiPlus MPSDevice
Multi-Purpose Solution for soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Opti Free RepliniSH | Active comparator | Opti Free RepliniSH Receives: Device: OPTI-FREE RepleniSH |
| ReNu Multi-Plus | Active comparator | ReNu Multi-Plus Receives: Device: ReNu MultiPlus MPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confocal microscopy analysis of Corneal Epithelium
Measured: 2 weeks
Secondary outcomes (2)
Patient comfort
Measured: 2 weeks
Corneal Staining
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens WearStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 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
- NCT00724269
- Sponsor's protocol ID
- SMA-08-04 / BP-08-01
- Status last verified
- Nov 2011
- First submitted
- 25 Jul 2008
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium
- ClinicalTrials.gov ID
- NCT00724269
- Acronym / sponsor ID
- SMA-08-04 / BP-08-01
- Conditions
- Contact Lens Wear
- Keywords
- Contact lens wear, multi-purpose solution, corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
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 corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opti Free RepliniSH | Active comparator | Device: OPTI-FREE RepleniSHOpti Free RepliniSH |
| ReNu Multi-Plus | Active comparator | Device: ReNu MultiPlus MPSReNu Multi-Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successful contact lens wear on a daily wear basis
- Wear contact lenses at least 8 hours/day
- Vision correctable to at least 20/30
- Normal Eyes
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (2 listed)
- Topical ocular medication use
- Other protocol-defined inclusion 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 |
|---|---|---|
| OPTI-FREE RepleniSHMulti-Purpose Solution for soft contact lenses | Device | Opti Free RepliniSH |
| ReNu MultiPlus MPSMulti-Purpose Solution for soft contact lenses | Device | ReNu Multi-Plus |
Primary outcome
Confocal microscopy analysis of Corneal Epithelium
Time frame: 2 weeks
2 secondary outcomes
Patient comfort
Time frame: 2 weeks
Corneal Staining
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
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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 OPTI-FREE RepleniSH and ReNu MultiPlus MPS in people with Contact Lens Wear, 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 2 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 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confocal microscopy analysis of Corneal Epithelium (time frame: 2 weeks). 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 1 Oct 2012.