Refractive ErrorNCT01484938

Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

A study testing OPTI-FREE PureMoist in people with Refractive Error, 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.

Trial summary

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: OPTI-FREE PureMoist
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 1 siteUnited States
Study dates: Feb 2011to May 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

18 years or older
Soft contact lens wear on a daily wear basis
Able to wear contact lenses for at least 8 hours
Generally healthy and have normal ocular health
Other protocol-defined inclusion criteria may apply

Who cannot join

No use of additional lens cleaners
No known sensitivities to any ingredient in the test article
No history of ocular surgery/trauma within the last six months
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, 76134

Other trials in United States

About this study

Conditions: Refractive Error
Being tested: OPTI-FREE PureMoist
Keywords: Soft contact lenses, Multi-purpose solution, Corneal staining
Medical subject headings: Refractive Errors

What participants receive

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

OPTI-FREE PureMoistDevice
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses

Study groups in NCT01484938
Study group	Role	What they receive
OPTI-FREE	Experimental	OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen Receives: Device: OPTI-FREE PureMoist

What is being measured

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

Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Measured: Baseline (Day 0), Day 30
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and 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 (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.
Measured: Baseline (Day 0), Day 30

Timeline

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

Feb 2011May 2011

First posted5 Dec 2011 (estimated)
Study startFeb 2011
Primary completionMay 2011
Study completionMay 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 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484938
Sponsor's protocol ID: C-10-017
Status last verified: Oct 2012
First submitted: 1 Dec 2011
Last updated: 10 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?

See locations

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT01484938
Acronym / sponsor ID: C-10-017
Conditions: Refractive Error
Keywords: Soft contact lenses, Multi-purpose solution, Corneal staining
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 5 Dec 2011 (estimated)
Results: Posted 8 Oct 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OPTI-FREE	Experimental	Device: OPTI-FREE PureMoistOPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen

Who may qualify

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

Key inclusion criteria (5 listed)

18 years or older
Soft contact lens wear on a daily wear basis
Able to wear contact lenses for at least 8 hours
Generally healthy and have normal ocular health
Other protocol-defined inclusion criteria may apply

Key exclusion criteria (4 listed)

No use of additional lens cleaners
No known sensitivities to any ingredient in the test article
No history of ocular surgery/trauma within the last six months
Other protocol-defined exclusion criteria may apply

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 PureMoistCommercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses	Device	OPTI-FREE

Primary outcome

Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Time frame: Baseline (Day 0), Day 30
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Time frame: Baseline (Day 0), Day 30
Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and 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 (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.

Results and safety

Results posted to the registry on 8 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	175	171

Primary outcome: Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30

Time frame: Baseline (Day 0), Day 30. Mean (Standard Deviation). Unit: Percentage of corneal staining

Measure	OPTI-FREE n = 171
Value	-5.04 (16.119)

Population analysed: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.

Primary outcome: Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30

Time frame: Baseline (Day 0), Day 30. Mean (Standard Deviation). Unit: Units on a scale

Measure	OPTI-FREE n = 171
Value	-0.82 (1.777)

Population analysed: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 3 months, 2 weeks, 2 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPTI-FREE	0 of 175 (0%)	0 of 175 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and 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.

Jami R Kern study director

Alcon Research

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 in people with Refractive Error, 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 5 inclusion and 4 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 10 Oct 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 8 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?

Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 (time frame: Baseline (Day 0), Day 30). 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 NCT01484938.

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 10 Oct 2012.