MyopiaNCT01211535

Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

A study testing OPTI-FREE RepleniSH multipurpose solution, ReNu Biotrue multipurpose solution and Silicone hydrogel contact lenses in people with Myopia and Astigmatism, run by Alcon Research at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism, Refractive Error
What is being tested?: OPTI-FREE RepleniSH multipurpose solution, ReNu Biotrue multipurpose solution and Silicone hydrogel contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Nov 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

Currently wearing silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Generally healthy;
Normal ocular health;
Willing to follow study procedures and visit schedule;
Sign Informed Consent and privacy document;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Use of additional lens cleaners;
Known sensitivities to any ingredient in either test article;
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
History of ocular surgery/trauma within the last 6 months;
Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Trial Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Conditions: Myopia, Astigmatism, Refractive Error
Being tested: OPTI-FREE RepleniSH multipurpose solution, ReNu Biotrue multipurpose solution, Silicone hydrogel contact lenses
Keywords: Soft contact lenses, Multi-purpose Solution
Medical subject headings: Myopia, Astigmatism, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPTI-FREE RepleniSH multipurpose solutionDevice
Also called OPTI-FREE® RepleniSH®
FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days
ReNu Biotrue multipurpose solutionDevice
Also called ReNu Biotrue™
FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days
Silicone hydrogel contact lensesDevice
Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Study groups in NCT01211535
Study group	Role	What they receive
OPTI-FREE RepleniSH	Experimental	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days Receives: Device: OPTI-FREE RepleniSH multipurpose solution; Device: Silicone hydrogel contact lenses
ReNu Biotrue	Active comparator	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days Receives: Device: ReNu Biotrue multipurpose solution; Device: Silicone hydrogel contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
Measured: Baseline (Day 0), Day 14

Timeline

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

Sep 2010Nov 2010

First posted29 Sep 2010 (estimated)
Study startSep 2010
Primary completionNov 2010
Study completionNov 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 MyopiaStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211535
Sponsor's protocol ID: SMA-09-59
Status last verified: Oct 2012
First submitted: 28 Sep 2010
Last updated: 12 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT01211535
Acronym / sponsor ID: SMA-09-59
Conditions: Myopia, Astigmatism, Refractive Error
Keywords: Soft contact lenses, Multi-purpose Solution
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 12 Nov 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 was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OPTI-FREE RepleniSH	Experimental	Device: OPTI-FREE RepleniSH multipurpose solution, Device: Silicone hydrogel contact lensesOPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
ReNu Biotrue	Active comparator	Device: ReNu Biotrue multipurpose solution, Device: Silicone hydrogel contact lensesReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Currently wearing silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Generally healthy;
Normal ocular health;
Willing to follow study procedures and visit schedule;

Key exclusion criteria (7 listed)

Use of additional lens cleaners;
Known sensitivities to any ingredient in either test article;
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
History of ocular surgery/trauma within the last 6 months;
Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;

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 RepleniSH multipurpose solutionAlso: OPTI-FREE® RepleniSH®FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days	Device	OPTI-FREE RepleniSH
ReNu Biotrue multipurpose solutionAlso: ReNu Biotrue™FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days	Device	ReNu Biotrue
Silicone hydrogel contact lensesSilicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care	Device	OPTI-FREE RepleniSH, ReNu Biotrue

Primary outcome

Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Time frame: Baseline (Day 0), Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Results and safety

Results posted to the registry on 12 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPTI-FREE RepleniSH	52	52
ReNu Biotrue	52	51

Primary outcome: Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14

Time frame: Baseline (Day 0), Day 14. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	OPTI-FREE RepleniSH n = 52	ReNu Biotrue n = 51
Baseline (Day 0)	87.40 (83.82 to 90.99)	88.79 (85.21 to 92.37)
Day 14	81.75 (78.17 to 85.33)	83.18 (79.56 to 86.79)
Change from Baseline (Day 0) at Day 14	-5.65 (-10.72 to -0.59)	-5.61 (-10.70 to -0.52)

Population analysed: All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)

Adverse events

Time frame: Adverse events were collected for the duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPTI-FREE RepleniSH	0 of 52 (0%)	0 of 52 (0%)	Not reported
ReNu Biotrue	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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.

1 site 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 7 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 12 Nov 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 12 Nov 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?

Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 (time frame: Baseline (Day 0), Day 14). 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 NCT01211535.

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 12 Nov 2012.