MyopiaNCT00772707

A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

A study testing Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH) and Contact Lenses in people with Myopia, 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 demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Myopia
What is being tested?: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH) and Contact Lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Oct 2008
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be between 18 and 65 years of age.
Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.
Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.

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Must be willing to maintain pre-enrollment systemic medication regimens during the study.
Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Has used any topical medication or rewetting drops for 7 days prior to enrollment.
Achieves best visual correction by monovision.
Has modified their systemic medications within 30 days prior to enrollment.
Has switched brands of cosmetics during the 30 days prior to the study.
Has a history of allergy to any study product ingredients.
Is unwilling or unable to meet the study visit timeline.
Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI-FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients

Conditions: Myopia
Being tested: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH), Contact Lenses
Keywords: contact lens solution, OPTI-FREE RepleniSH, contact lenses
Medical subject headings: Myopia

What participants receive

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

Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)Device
Also called OPTI-FREE RepleniSH®
OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.
Contact LensesDevice
Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.

Study groups in NCT00772707
Study group	Role	What they receive
Opti-Free Replenish	Experimental	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days. Receives: Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH); Device: Contact Lenses

What is being measured

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

Comfort Ratings at Baseline
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Measured: Baseline (Day 0)
Comfort Ratings at 30 Days
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Measured: 30 days

Timeline

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

Sep 2008Oct 2008

First posted15 Oct 2008 (estimated)
Study startSep 2008
Primary completionOct 2008
Study completionOct 2008

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772707
Sponsor's protocol ID: SMA-08-14
Status last verified: Aug 2012
First submitted: 7 Oct 2008
Last updated: 7 Sep 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI-FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients
ClinicalTrials.gov ID: NCT00772707
Acronym / sponsor ID: SMA-08-14
Conditions: Myopia
Keywords: contact lens solution, OPTI-FREE RepleniSH, contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Opti-Free Replenish	Experimental	Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH), Device: Contact LensesMulti-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Participants must be between 18 and 65 years of age.
Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.

Key exclusion criteria (8 listed)

Has used any topical medication or rewetting drops for 7 days prior to enrollment.
Achieves best visual correction by monovision.
Has modified their systemic medications within 30 days prior to enrollment.
Has switched brands of cosmetics during the 30 days prior to the study.
Has a history of allergy to any study product ingredients.

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
Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)Also: OPTI-FREE RepleniSH®OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.	Device	Opti-Free Replenish
Contact LensesContact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.	Device	Opti-Free Replenish

Primary outcome

Comfort Ratings at Baseline
Time frame: Baseline (Day 0)
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Comfort Ratings at 30 Days
Time frame: 30 days
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

Results and safety

Results posted to the registry on 3 Sep 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	114	111

Primary outcome: Comfort Ratings at Baseline

Time frame: Baseline (Day 0). Number. Unit: Percentage of Participants

Measure	Opti-Free Replenish n = 108
My lens is comfortable upon instillation	86
My lenses feel comfortable at the end of the day	59
My vision is clear at the end of the day	57
I am satisfied with my overall lens experience	81

Population analysed: 6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).

Primary outcome: Comfort Ratings at 30 Days

Time frame: 30 days. Number. Unit: Percentage of Participants

Measure	Opti-Free Replenish n = 109
My lens is comfortable upon instillation	92
My lenses feel comfortable at the end of the day	88
My vision is clear at the end of the day	91
I am satisfied with my overall lens experience	91
Study product enhances wearing experience more	71
I will continue to use the study solution after	81

Population analysed: 5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).

Adverse events

Time frame: Adverse events were collected for the duration of the study: 1 month, 12 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Opti-Free Replenish	0 of 114 (0%)	0 of 114 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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 Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH) and Contact Lenses in people with Myopia, 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 9 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 7 Sep 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 3 Sep 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?

Comfort Ratings at Baseline (time frame: Baseline (Day 0)). 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 NCT00772707.

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 7 Sep 2012.