Refractive ErrorNCT01809197

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

A study testing Lotrafilcon B contact lenses, Senofilcon A contact lenses and OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) in people with Refractive Error and Myopia, 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 compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error, Myopia, Hyperopia
What is being tested?: Lotrafilcon B contact lenses, Senofilcon A contact lenses and OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 387 participants
Where: No sites listed yet
Study dates: Apr 2013to Jul 2013
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

Sign informed consent.
Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
Willing to wear contact lenses on a daily wear basis for the duration of the study.
Currently using a multi-purpose solution, as specified in protocol.
Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.
Willing to follow the study procedures and visit schedule.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
Currently using any Opti-Free brand of multi-purpose solution.
Must wear contact lenses on an extended wear (overnight) basis during the study.
Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.

Show all 13Show fewer

Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.
Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.
Ocular surgery within the 12 months prior to Visit 1.
Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
Participation in any clinical study within 30 days of Visit 1.
Other protocol-defined exclusion criteria may apply.

About this study

Read the detailed description

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Conditions: Refractive Error, Myopia, Hyperopia, Astigmatism, Presbyopia
Being tested: Lotrafilcon B contact lenses, Senofilcon A contact lenses, OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS), Habitual Multi-Purpose Solution (MPS)
Keywords: Refractive error, Myopia, Hyperopia, Astigmatism, Presbyopia, Contact lenses, Contact lens solution, Comfort
Medical subject headings: Refractive Errors, Myopia, Hyperopia, Astigmatism, Presbyopia

What participants receive

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

Lotrafilcon B contact lensesDevice
Also called AIR OPTIX® AQUA, AIR OPTIX® AQUA Multifocal, AIR OPTIX® for Astigmatism
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Senofilcon A contact lensesDevice
Also called ACUVUE® OASYS® with HYDRACLEAR® PLUS, ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS, ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)Device
Also called OPTI-FREE® PureMoist™
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
Habitual Multi-Purpose Solution (MPS)Device
Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Study groups in NCT01809197
Study group	Role	What they receive
Air Optix/OFPM	Experimental	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system Receives: Device: Lotrafilcon B contact lenses; Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Acuvue Oasys/Habitual MPS	Active comparator	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system Receives: Device: Senofilcon A contact lenses; Device: Habitual Multi-Purpose Solution (MPS)

What is being measured

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

Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Measured: Day 30; after 4 hours of lens wear

Timeline

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

Apr 2013Jul 2013

First posted12 Mar 2013 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionJul 2013

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 Refractive ErrorStudies 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: Single blind
Who is masked: Participant
Enrolment: 387 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01809197
Sponsor's protocol ID: M-12-056
Status last verified: Jun 2014
First submitted: 8 Mar 2013
Last updated: 22 Jul 2014
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

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
ClinicalTrials.gov ID: NCT01809197
Acronym / sponsor ID: M-12-056
Conditions: Refractive Error, Myopia, Hyperopia, Astigmatism, Presbyopia
Keywords: Refractive error, Myopia, Hyperopia, Astigmatism, Presbyopia, Contact lenses, Contact lens solution, Comfort
Study type: Interventional
Recruitment status: Completed
Enrolment: 387 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 12 Mar 2013 (estimated)
Results: Posted 22 Jul 2014

Clinical summary

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

Detailed description

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Study design

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

Arm	Type	Receives
Air Optix/OFPM	Experimental	Device: Lotrafilcon B contact lenses, Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
Acuvue Oasys/Habitual MPS	Active comparator	Device: Senofilcon A contact lenses, Device: Habitual Multi-Purpose Solution (MPS)Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system

Who may qualify

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

Key inclusion criteria (7 listed)

Sign informed consent.
Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
Willing to wear contact lenses on a daily wear basis for the duration of the study.
Currently using a multi-purpose solution, as specified in protocol.
Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.

Key exclusion criteria (13 listed)

Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
Currently using any Opti-Free brand of multi-purpose solution.
Must wear contact lenses on an extended wear (overnight) basis during the study.
Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.

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
Lotrafilcon B contact lensesAlso: AIR OPTIX® AQUA, AIR OPTIX® AQUA Multifocal, AIR OPTIX® for AstigmatismSilicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions	Device	Air Optix/OFPM
Senofilcon A contact lensesAlso: ACUVUE® OASYS® with HYDRACLEAR® PLUS, ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS, ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUSSilicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions	Device	Acuvue Oasys/Habitual MPS
OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)Also: OPTI-FREE® PureMoist™Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions	Device	Air Optix/OFPM
Habitual Multi-Purpose Solution (MPS)Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions	Device	Acuvue Oasys/Habitual MPS

Primary outcome

Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
Time frame: Day 30; after 4 hours of lens wear
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

Results and safety

Results posted to the registry on 22 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Air Optix/OFPM	187	177
Acuvue Oasys/Habitual MPS	185	177

Primary outcome: Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"

Time frame: Day 30; after 4 hours of lens wear. Least squares mean (Standard Deviation). Unit: units on a scale

Measure	Air Optix/OFPM n = 178	Acuvue Oasys/Habitual MPS n = 177
Value	4.2 (0.90)	4.4 (0.66)

Population analysed: This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.

Adverse events

Time frame: Adverse events (AEs) were collected for duration of study (3 months). This analysis group includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed study lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Air Optix/OFPM	0 of 187 (0%)	0 of 187 (0%)	Not reported
Acuvue Oasys/Habitual MPS	0 of 184 (0%)	0 of 184 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
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Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
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Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Not yet recruiting
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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.

Jessie Lemp, PhD study director

Alcon Research

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 13 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 22 Jul 2014. 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 22 Jul 2014). 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?

Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" (time frame: Day 30; after 4 hours of lens wear). 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 NCT01809197.

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 22 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.