Contact Lens WearNCT01164865

Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

A study testing OPTI-FREE RepleniSH multipurpose disinfecting solution, Clear Care contact lens care system and Contact lenses in people with Contact Lens Wear, run by Alcon Research.

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 comfort in soft contact lens wearers. 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 multipurpose disinfecting solution, Clear Care contact lens care system and Contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: Jun 2010to Dec 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

Wear silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
Read, sign, and date IRB-approved informed consent and the privacy document;
Be generally healthy and have normal ocular health;
Be be willing to follow the study procedures and visit schedule;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Use of additional lens cleaners;
Known sensitivity to any ingredient in either of the test articles;
Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
Prior (within 7 days of enrollment) or current ocular infections;
Clinically significant lash or lid abnormality;
History of ocular surgery/trauma within the last 6 months;

Show all 9Show fewer

Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

The purpose of this study was to assess comfort in soft contact lens wearers.

Conditions: Contact Lens Wear
Being tested: OPTI-FREE RepleniSH multipurpose disinfecting solution, Clear Care contact lens care system, Contact lenses
Keywords: Soft Contact lens, Multi-Purpose Solution, Hydrogen Peroxide

What participants receive

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

OPTI-FREE RepleniSH multipurpose disinfecting solutionDevice
Also called OPTI-FREE® RepleniSH®
FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
Clear Care contact lens care systemDevice
Also called Clear Care®
FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
Contact lensesDevice
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.

Study groups in NCT01164865
Study group	Role	What they receive
OPTI-FREE RepleniSH	Experimental	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. Receives: Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Contact lenses
Clear Care	Active comparator	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. Receives: Device: Clear Care contact lens care system; Device: Contact lenses

What is being measured

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

Change From Baseline in Ocular Comfort Rating at 2 Weeks
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."
Measured: Baseline (Day 0), 2 weeks
Likert Questionnaire Scores at 2 Weeks
The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.
Measured: 2 weeks

Timeline

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

Jun 2010Dec 2010

First posted19 Jul 2010 (estimated)
Study startJun 2010
Primary completionDec 2010
Study completionDec 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.
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: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01164865
Sponsor's protocol ID: SMA-09-58
Status last verified: Sep 2012
First submitted: 15 Jul 2010
Last updated: 12 Oct 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?

Official record

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 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT01164865
Acronym / sponsor ID: SMA-09-58
Conditions: Contact Lens Wear
Keywords: Soft Contact lens, Multi-Purpose Solution, Hydrogen Peroxide
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Jul 2010 (estimated)
Results: Posted 12 Oct 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 comfort 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 disinfecting solution, Device: Contact lensesOPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Clear Care	Active comparator	Device: Clear Care contact lens care system, Device: Contact lensesClear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.

Who may qualify

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

Key inclusion criteria (7 listed)

Wear silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
Read, sign, and date IRB-approved informed consent and the privacy document;
Be generally healthy and have normal ocular health;

Key exclusion criteria (9 listed)

Use of additional lens cleaners;
Known sensitivity to any ingredient in either of the test articles;
Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
Prior (within 7 days of enrollment) or current ocular infections;
Clinically significant lash or lid abnormality;

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 disinfecting solutionAlso: OPTI-FREE® RepleniSH®FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.	Device	OPTI-FREE RepleniSH
Clear Care contact lens care systemAlso: Clear Care®FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.	Device	Clear Care
Contact lensesContact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.	Device	Clear Care, OPTI-FREE RepleniSH

Primary outcome

Change From Baseline in Ocular Comfort Rating at 2 Weeks
Time frame: Baseline (Day 0), 2 weeks
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."
Likert Questionnaire Scores at 2 Weeks
Time frame: 2 weeks
The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.

Results and safety

Results posted to the registry on 12 Oct 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	39	37
Clear Care	39	38

Primary outcome: Change From Baseline in Ocular Comfort Rating at 2 Weeks

Time frame: Baseline (Day 0), 2 weeks. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	OPTI-FREE RepleniSH n = 37	Clear Care n = 38
Value	-8.20 (-13.84 to -2.55)	-7.14 (-12.74 to -1.54)

Population analysed: All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.

Primary outcome: Likert Questionnaire Scores at 2 Weeks

Time frame: 2 weeks. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	OPTI-FREE RepleniSH n = 37	Clear Care n = 38
I can comfortably wear my lenses	4.20 (3.96 to 4.44)	4.24 (4.00 to 4.48)
My lenses stay moist from morning to evening	3.60 (3.28 to 3.92)	3.69 (3.37 to 4.01)
The solution I use feels gentle on my eyes	4.00 (3.75 to 4.25)	3.66 (3.41 to 3.91)
My lenses feel fresh	3.79 (3.52 to 4.05)	4.03 (3.77 to 4.29)
At the end of the day, my vision is clear	3.54 (3.20 to 3.88)	3.86 (3.52 to 4.19)
When I put my lenses in, they feel comfortable	4.05 (3.78 to 4.33)	4.03 (3.76 to 4.30)
I like the way this product feels during handling	4.09 (3.84 to 4.34)	3.66 (3.42 to 3.91)
My lenses feel moist	3.84 (3.56 to 4.12)	3.64 (3.36 to 3.92)

Population analysed: All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 5 months, 3 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPTI-FREE RepleniSH	0 of 39 (0%)	0 of 39 (0%)	Not reported
Clear Care	0 of 39 (0%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

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

Questions about this trial

What is this clinical trial studying?

A study testing OPTI-FREE RepleniSH multipurpose disinfecting solution, Clear Care contact lens care system and Contact lenses in people with Contact Lens Wear, run by Alcon Research.

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 9 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 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

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 Oct 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 in Ocular Comfort Rating at 2 Weeks (time frame: Baseline (Day 0), 2 weeks). 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 NCT01164865.

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 Oct 2012.