Contact Lens WearNCT01055457

Vistakon Investigational Multi-purpose Contact Lens Care Solution.

A study testing Vistakon Investigational Multi-Purpose Solution II and ReNu MultiPlus Multi-Purpose Solution in people with Contact Lens Wear, run by Johnson & Johnson Vision Care, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 II 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: 315 participants
Where: 14 sitesUnited States
Study dates: 1 Nov 2009to 1 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

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Amarillo, Texas
Study site
Athens, Ohio
Study site
Bloomington, Illinois
Study site
Charlottesville, Virginia
Study site
Jamestown, New York
Study site
Katy, Texas
Study site
Mission Viejo, California
Study site
Moon Township, Pennsylvania
Study site
Orlando, Florida
Study site
Pittsburg, Kansas
Study site
Salt Lake City, Utah
Study site
State College, Pennsylvania
Study site
Tallahassee, Florida
Study site
Vestal, New York

Other trials in United States

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 II, 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 IIDevice
contact lens care solution
ReNu MultiPlus Multi-Purpose SolutionDevice
contact lens care solution

Study groups in NCT01055457
Study group	Role	What they receive
Experimental Multi-Purpose Solution	Experimental	contact lens care solution Receives: Device: Vistakon Investigational Multi-Purpose Solution II
ReNu MultiPlus Multi-Purpose Solution	Active comparator	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 (SLF)
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Measured: Up to 3 months Post Lens Wear
Distance Visual Acuity (LogMAR)
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
Measured: Up to 3 Months Post Lens Wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20091 May 2010

First posted25 Jan 2010 (estimated)
Study start1 Nov 2009
Primary completion1 May 2010
Study completion1 May 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: 315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01055457
Sponsor's protocol ID: CR-1650
Status last verified: Aug 2017
First submitted: 22 Jan 2010
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
Active, not recruiting
The A.R.R.E.S.T.® Contact Lens Study
Myopia, Myopia Progression
RecruitingPhase 4
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Dry Eye
Enrolling by invitation
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
Healthy Participants Study, Contact Lens Wear
Active, not recruiting
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Myopia

All Contact Lens Wear trials

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: Vistakon Investigational Multi-purpose Contact Lens Care Solution.
ClinicalTrials.gov ID: NCT01055457
Acronym / sponsor ID: CR-1650
Conditions: Contact Lens Wear
Study type: Interventional
Recruitment status: Completed
Enrolment: 315 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2009 (actual)
Primary completion: 1 May 2010 (actual)
Study completion: 1 May 2010 (actual)
First posted: 25 Jan 2010 (estimated)
Results: Posted 24 Jan 2017

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 IIcontact lens care solution
ReNu MultiPlus Multi-Purpose Solution	Active comparator	Device: ReNu MultiPlus Multi-Purpose Solutioncontact 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 IIcontact lens care solution	Device	Experimental Multi-Purpose Solution
ReNu MultiPlus Multi-Purpose Solutioncontact lens care solution	Device	ReNu MultiPlus Multi-Purpose Solution

Primary outcome

Slit Lamp Findings (SLF)
Time frame: Up to 3 months Post Lens Wear
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Distance Visual Acuity (LogMAR)
Time frame: Up to 3 Months Post Lens Wear
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.

Results and safety

Results posted to the registry on 24 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solution1 (Etafilcon A)	40	39
Solution1 (Comfilcon A)	40	39
Solution1 (Balafilcon A)	38	36
Solution1 (Lotrafilcon A)	40	37
Solution1 (Galyfilcon A)	41	38
Solution2 (Etafilcon A)	18	15
Solution2 (Comfilcon A)	19	18
Solution2 (Balafilcon A)	19	18
Solution2 (Lotrafilcon A)	20	20
Solution2 (Galyfilcon A)	20	19

Primary outcome: Slit Lamp Findings (SLF)

Time frame: Up to 3 months Post Lens Wear. Number. Unit: eyes (2 per subject)

Measure	Solution1 (Etafilcon A) n = 39	Solution1 (Comfilcon A) n = 39	Solution1 (Balafilcon A) n = 36	Solution1 (Lotrafilcon A) n = 37	Solution1 (Galyfilcon A) n = 38	Solution2 (Etafilcon A) n = 15	Solution2 (Comfilcon A) n = 18	Solution2 (Balafilcon A) n = 18	Solution2 (Lotrafilcon A) n = 20	Solution2 (Galyfilcon A) n = 19
Edema	0	0	0	0	0	0	0	0	0	0
Corneal Neovascularization	0	0	0	0	0	0	0	0	0	0
Corneal Staining	8	16	14	12	6	8	3	28	12	8
Injection	1	0	1	0	3	1	2	4	0	3
Tarsal Abnormalities	15	10	10	10	2	0	1	6	9	1
Other Findings	6	3	1	0	0	0	0	0	0	0

Population analysed: All subjects that completed the study.

Primary outcome: Distance Visual Acuity (LogMAR)

Time frame: Up to 3 Months Post Lens Wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Solution1 (Etafilcon A) n = 39	Solution1 (Comfilcon A) n = 39	Solution1 (Balafilcon A) n = 36	Solution1 (Lotrafilcon A) n = 37	Solution1 (Galyfilcon A) n = 38	Solution2 (Etafilcon A) n = 15	Solution2 (Comfilcon A) n = 18	Solution2 (Balafilcon A) n = 18	Solution2 (Lotrafilcon A) n = 20	Solution2 (Galyfilcon A) n = 19
1-week	-0.033 (0.0601)	-0.042 (0.0630)	-0.037 (0.0563)	-0.040 (0.0665)	-0.029 (0.0615)	-0.055 (0.0580)	-0.033 (0.0601)	-0.040 (0.0540)	-0.045 (0.0685)	-0.012 (0.0619)
2-week	-0.045 (0.0642)	-0.041 (0.0663)	-0.047 (0.0592)	-0.039 (0.0649)	-0.037 (0.0594)	-0.058 (0.0585)	-0.045 (0.0642)	-0.051 (0.0625)	-0.031 (0.0551)	-0.030 (0.0595)
1-Month	-0.045 (0.0623)	-0.042 (0.0644)	-0.033 (0.0658)	-0.040 (0.0628)	-0.037 (0.0595)	-0.068 (0.0541)	-0.045 (0.0623)	-0.026 (0.0534)	-0.031 (0.0626)	-0.032 (0.0610)
3-Month	-0.045 (0.0673)	-0.031 (0.0609)	-0.039 (0.0617)	-0.038 (0.0607)	-0.031 (0.0613)	-0.051 (0.0668)	-0.045 (0.0673)	-0.034 (0.0567)	-0.014 (0.0618)	-0.040 (0.0614)

Population analysed: All subjects that completed the study.

Adverse events

Time frame: Throughout the duration of the study. Approximately 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solution1 (Etafilcon A)	0 of 40 (0%)	0 of 40 (0%)	Not reported
Solution1 (Comfilcon A)	0 of 40 (0%)	0 of 40 (0%)	Not reported
Solution1 (Balafilcon A)	0 of 38 (0%)	0 of 38 (0%)	Not reported
Solution1 (Lotrafilcon A)	1 of 40 (2.5%)	0 of 40 (0%)	Not reported
Solution1 (Galyfilcon A)	0 of 41 (0%)	2 of 41 (4.9%)	Not reported
Solution2 (Etafilcon A)	0 of 18 (0%)	0 of 18 (0%)	Not reported
Solution2 (Comfilcon A)	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Solution2 (Balafilcon A)	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Solution2 (Lotrafilcon A)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Solution2 (Galyfilcon A)	0 of 20 (0%)	1 of 20 (5%)	Not reported

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.

Related trials for Contact Lens Wear

Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
Active, not recruiting
The A.R.R.E.S.T.® Contact Lens Study
Myopia, Myopia Progression
RecruitingPhase 4
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Dry Eye
Enrolling by invitation
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
Healthy Participants Study, Contact Lens Wear
Active, not recruiting
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Myopia

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.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 24 Jan 2017). 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 (SLF) (time frame: Up to 3 months Post Lens Wear). 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?

On the ClinicalTrials.gov record for NCT01055457.

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.