Contact Lens WearNCT01055613
Investigational Multi-purpose Contact Lens Care Solution.
A study testing Vistakon Investigational Multi-Purpose Solution I and ReNu MultiPlus Multi-Purpose Solution in people with Contact Lens Wear, run by Johnson & Johnson Vision Care, Inc. at 15 sites in United States.
Trial summary
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution. 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?
- Vistakon Investigational Multi-Purpose Solution I and ReNu MultiPlus Multi-Purpose Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 15 sitesUnited 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be an adapted contact lens wearer
- best corrected distance visual acuity must be 20/25 or better in each eye
- must be wearing their habitual lenses on a daily wear basis
- must be willing to refrain from swimming during the study
Who cannot join
- any systemic diseases that may interfere with contact lens wear
- any clinically significant ocular disease
- any ocular infection
- use of certain medications
- any grade 2 or greater slit lamp findings
- any know sensitivity to marketed contact lens care solutions
- currently pregnant or lactating
- monovision corrected
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Bloomfield, Connecticut
Study site
East Lansing, Michigan
Study site
Fresno, California
Study site
Grants Pass, Oregon
Study site
Grove City, Ohio
Study site
Jacksonville, Florida
Study site
Kingston, Pennsylvania
Study site
Laramie, Wyoming
Study site
Louisville, Colorado
Study site
Memphis, Tennessee
Study site
Overland Park, Kansas
Study site
Pismo Beach, California
Study site
Salt Lake City, Utah
Study site
Sioux Falls, South Dakota
Study site
Warrensburg, Missouri
About this study
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
- Conditions
- Contact Lens Wear
- Being tested
- Vistakon Investigational Multi-Purpose Solution I, ReNu MultiPlus Multi-Purpose Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vistakon Investigational Multi-Purpose Solution IDevice
Multi-purpose contact lens care solution.
ReNu MultiPlus Multi-Purpose SolutionDevice
Multi-purpose contact lens care solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental multi-purpose solution | Experimental | Multi-purpose contact lens care solution. Receives: Device: Vistakon Investigational Multi-Purpose Solution I |
| ReNu MultiPlus Multi-Purpose Solution | Active comparator | Multi-purpose contact lens care solution. Receives: Device: ReNu MultiPlus Multi-Purpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
Measured: 3 months
Distance Visual Acuity (LogMAR)
Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startNov 2009
- Primary 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 Contact Lens WearStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055613
- Sponsor's protocol ID
- CR-1624
- Status last verified
- Jul 2016
- First submitted
- 22 Jan 2010
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Multi-purpose Contact Lens Care Solution.
- ClinicalTrials.gov ID
- NCT01055613
- Acronym / sponsor ID
- CR-1624
- Conditions
- Contact Lens Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental multi-purpose solution | Experimental | Device: Vistakon Investigational Multi-Purpose Solution IMulti-purpose contact lens care solution. |
| ReNu MultiPlus Multi-Purpose Solution | Active comparator | Device: ReNu MultiPlus Multi-Purpose SolutionMulti-purpose contact lens care solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must be an adapted contact lens wearer
- best corrected distance visual acuity must be 20/25 or better in each eye
- must be wearing their habitual lenses on a daily wear basis
- must be willing to refrain from swimming during the study
Key exclusion criteria (8 listed)
- any systemic diseases that may interfere with contact lens wear
- any clinically significant ocular disease
- any ocular infection
- use of certain medications
- any grade 2 or greater slit lamp findings
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 |
|---|---|---|
| Vistakon Investigational Multi-Purpose Solution IMulti-purpose contact lens care solution. | Device | Experimental multi-purpose solution |
| ReNu MultiPlus Multi-Purpose SolutionMulti-purpose contact lens care solution | Device | ReNu MultiPlus Multi-Purpose Solution |
Primary outcome
Slit Lamp Findings
Time frame: 3 months
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
Distance Visual Acuity (LogMAR)
Time frame: Up to 3 Months
Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vistakon Investigational Multi-Purpose Solution I and ReNu MultiPlus Multi-Purpose Solution in people with Contact Lens Wear, run by Johnson & Johnson Vision Care, Inc. at 15 sites 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 4 inclusion and 8 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 31 Aug 2016). 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?
Slit Lamp Findings (time frame: 3 months). 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 19 Jun 2018.