Contact Lens SolutionNCT00691457
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina
A study testing Opti-Free contact lens solution, ReNu Multiplus contact lens solution and Clear Care contact lens solution in people with Contact Lens Solution, run by Alcon Research at 1 site in United States.
Trial summary
Three arm study comparing three novel contact lens solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Solution
- What is being tested?
- Opti-Free contact lens solution, ReNu Multiplus contact lens solution and Clear Care contact lens solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2009
- 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
- Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
- Stable correction is defined as longer than six months.
- Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months
Who cannot join
- Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
- Any systemic or ocular disease that could affect contact lens wear.
- Women who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Three arm study comparing three novel contact lens solutions.
- Conditions
- Contact Lens Solution
- Being tested
- Opti-Free contact lens solution, ReNu Multiplus contact lens solution, Clear Care contact lens solution
- Keywords
- Contact lens, solution, confocal microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free contact lens solutionDevice
Solution
ReNu Multiplus contact lens solutionDevice
Solution
Clear Care contact lens solutionDevice
Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Opti-Free contact lens solution Receives: Device: Opti-Free contact lens solution |
| 2 | Active comparator | ReNu Multiplus contact lens solution Receives: Device: ReNu Multiplus contact lens solution |
| 3 | Active comparator | Clear Care contact lens solution Receives: Device: Clear Care contact lens solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in corneal fluorescein staining as evaluated at Day 30
Measured: 30 Days
Secondary outcomes (1)
Confocal evaluation variables as measured at Days 0, 14, and 30
Measured: Day 0, 14, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens SolutionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 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
- NCT00691457
- Sponsor's protocol ID
- SMA-08-09
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 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 3 Novel Contact Lens Solutions on the Basal Lamina
- ClinicalTrials.gov ID
- NCT00691457
- Acronym / sponsor ID
- SMA-08-09
- Conditions
- Contact Lens Solution
- Keywords
- Contact lens, solution, confocal microscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Jun 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.
Three arm study comparing three novel contact lens solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Opti-Free contact lens solutionOpti-Free contact lens solution |
| 2 | Active comparator | Device: ReNu Multiplus contact lens solutionReNu Multiplus contact lens solution |
| 3 | Active comparator | Device: Clear Care contact lens solutionClear Care contact lens solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
- Stable correction is defined as longer than six months.
- Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months
Key exclusion criteria (3 listed)
- Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
- Any systemic or ocular disease that could affect contact lens wear.
- Women who are pregnant or lactating.
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 contact lens solutionSolution | Device | 1 |
| ReNu Multiplus contact lens solutionSolution | Device | 2 |
| Clear Care contact lens solutionSolution | Device | 3 |
Primary outcome
Change from baseline in corneal fluorescein staining as evaluated at Day 30
Time frame: 30 Days
1 secondary outcome
Confocal evaluation variables as measured at Days 0, 14, and 30
Time frame: Day 0, 14, 30
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 contact lens solution, ReNu Multiplus contact lens solution and Clear Care contact lens solution in people with Contact Lens Solution, 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 3 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?
Change from baseline in corneal fluorescein staining as evaluated at Day 30 (time frame: 30 Days). 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.