HealthyNCT01476722

Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)

A study testing OPTI-FREE PureMoist multipurpose disinfecting solution in people with Healthy, 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 evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Healthy
What is being tested?: OPTI-FREE PureMoist multipurpose disinfecting solution
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Oct 2011
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 or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
Read, sign, and date IRB-approved informed consent and privacy document;
Be generally healthy and have normal ocular health;
Willing to follow the study procedures and visit schedule;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Wear lenses on an extended wear basis during the study;
Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
Monocular subject;
Requirestoric or multifocal contact lenses;
Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;

Show all 12Show fewer

Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;
Ocular surgery within the 12 months prior to Visit 1;
Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;
Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;
Participation in any clinical study within 30 days of Visit 1;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76314

Other trials in United States

About this study

Official title: Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)

The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.

Conditions: Healthy
Being tested: OPTI-FREE PureMoist multipurpose disinfecting solution
Keywords: Silicone Hydrogel, Soft Contact Lenses, Multi-Purpose Solution

What participants receive

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

OPTI-FREE PureMoist multipurpose disinfecting solutionDevice
FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days

Study groups in NCT01476722
Study group	Role	What they receive
OPTI-FREE PureMoist	Experimental	OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days Receives: Device: OPTI-FREE PureMoist multipurpose disinfecting solution

What is being measured

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

Corneal Fluorescein Staining Type at Baseline
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Measured: Day 0 (Baseline)
Corneal Fluorescein Staining Type at Day 30
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Measured: Day 30
Corneal Fluorescein Staining Area at Baseline
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Measured: Day 0 (Baseline)
Corneal Fluorescein Staining Area at Day 30
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Measured: Day 30

Timeline

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

Jun 2011Oct 2011

First posted22 Nov 2011 (estimated)
Study startJun 2011
Primary completionOct 2011
Study completionOct 2011

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 HealthyStudies 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: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01476722
Sponsor's protocol ID: RDG-11-149
Status last verified: Nov 2012
First submitted: 18 Nov 2011
Last updated: 19 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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)
ClinicalTrials.gov ID: NCT01476722
Acronym / sponsor ID: RDG-11-149
Conditions: Healthy
Keywords: Silicone Hydrogel, Soft Contact Lenses, Multi-Purpose Solution
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 22 Nov 2011 (estimated)
Results: Posted 19 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 evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
OPTI-FREE PureMoist	Experimental	Device: OPTI-FREE PureMoist multipurpose disinfecting solutionOPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 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)

Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
Read, sign, and date IRB-approved informed consent and privacy document;
Be generally healthy and have normal ocular health;

Key exclusion criteria (12 listed)

Wear lenses on an extended wear basis during the study;
Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
Monocular subject;
Requirestoric or multifocal contact lenses;
Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;

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 PureMoist multipurpose disinfecting solutionFDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days	Device	OPTI-FREE PureMoist

Primary outcome

Corneal Fluorescein Staining Type at Baseline
Time frame: Day 0 (Baseline)
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Type at Day 30
Time frame: Day 30
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Area at Baseline
Time frame: Day 0 (Baseline)
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Area at Day 30
Time frame: Day 30
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

Results and safety

Results posted to the registry on 19 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 PureMoist	125	124

Primary outcome: Corneal Fluorescein Staining Type at Baseline

Time frame: Day 0 (Baseline). Mean (Standard Deviation). Unit: Units on a scale

Measure	OPTI-FREE PureMoist n = 124
Value	1.7 (1.38)

Population analysed: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Primary outcome: Corneal Fluorescein Staining Type at Day 30

Time frame: Day 30. Mean (Standard Deviation). Unit: Units on a scale

Measure	OPTI-FREE PureMoist n = 124
Value	0.7 (0.94)

Population analysed: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Primary outcome: Corneal Fluorescein Staining Area at Baseline

Time frame: Day 0 (Baseline). Mean (Standard Deviation). Unit: Units on a scale

Measure	OPTI-FREE PureMoist n = 124
Value	5.6 (9.34)

Population analysed: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Primary outcome: Corneal Fluorescein Staining Area at Day 30

Time frame: Day 30. Mean (Standard Deviation). Unit: Units on a scale

Measure	OPTI-FREE PureMoist n = 124
Value	1.4 (2.41)

Population analysed: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.

Adverse events

Time frame: Adverse events were collected for the duration of the study (e.g., 4 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPTI-FREE PureMoist	0 of 125 (0%)	0 of 125 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 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?

A study testing OPTI-FREE PureMoist multipurpose disinfecting solution in people with Healthy, 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 7 inclusion and 12 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 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 19 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?

Corneal Fluorescein Staining Type at Baseline (time frame: Day 0 (Baseline)). The study lists 4 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 NCT01476722.

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 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.