MyopiaNCT01699750

Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

A study testing Lotrafilcon B contact lenses, Senofilcon A contact lenses and OPTI-FREE® PUREMOIST® MPDS in people with Myopia and Astigmatism, 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 is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism, Refractive Error
What is being tested?: Lotrafilcon B contact lenses, Senofilcon A contact lenses and OPTI-FREE® PUREMOIST® MPDS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Nov 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

Read and understand the Participant Information Sheet;
Read, sign, and date the Informed Consent;
Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
Best corrected visual acuity of 6/9 or better in each eye;
Normal eyes with the exception of the need for visual correction;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
Systemic or ocular allergies which might interfere with contact lens wear;
Ocular disease which might interfere with contact lens wear;

Show all 12Show fewer

Active ocular infection;
Use of any concomitant topical ocular medications during the study period;
Previous ocular surgery;
Pregnant, planning to become pregnant, or lactating at the time of enrollment;
Participation in an investigational drug or device study within 30 days of entering this study;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Read the detailed description

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Conditions: Myopia, Astigmatism, Refractive Error
Being tested: Lotrafilcon B contact lenses, Senofilcon A contact lenses, OPTI-FREE® PUREMOIST® MPDS, BIOTRUE®, Balafilcon A contact lenses
Keywords: contact lenses, contact lens solution, myopia, astigmatism
Medical subject headings: Myopia, Astigmatism, Refractive Errors

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, AOA
Silicone hydrogel contact lenses, Phase 2
Senofilcon A contact lensesDevice
Also called ACUVUE® OASYS® with HYDRACLEAR®, AVO
Silicone hydrogel contact lenses, Phase 2
OPTI-FREE® PUREMOIST® MPDSDevice
Also called OFPM
Contact lens care system, Phase 2
BIOTRUE®Device
Contact lens care system, Phase 2
Balafilcon A contact lensesDevice
Also called PureVision
Silicone hydrogel contact lenses worn for 30 days, Phase 1
ReNu® Multiplus®Device
Contact lens care system used for 30 days, Phase 1

Study groups in NCT01699750
Study group	Role	What they receive
Air Optix Aqua	Experimental	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each Receives: Device: Lotrafilcon B contact lenses; Device: OPTI-FREE® PUREMOIST® MPDS; Device: BIOTRUE®; Device: Balafilcon A contact lenses; Device: ReNu® Multiplus®
Acuvue Oasys	Active comparator	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each Receives: Device: Senofilcon A contact lenses; Device: OPTI-FREE® PUREMOIST® MPDS; Device: BIOTRUE®; Device: Balafilcon A contact lenses; Device: ReNu® Multiplus®

What is being measured

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

Mean Ex-Vivo Total Lipid Uptake Per Lens
The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.
Measured: Day 30

Secondary outcomes (6)

Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.
Measured: Day 30
LogMAR Time-Controlled Visual Acuity (TCVA)
Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.
Measured: Day 30
Overall Comfort Measured With Visual Analog Scale (VAS)
The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Measured: Day 30
Overall Dryness Measured With Visual Analog Scale (VAS)
The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Measured: Day 30
Average Exposure Speed
Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.
Measured: Day 30
Minimum Protected Area
Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.
Measured: Day 30

Timeline

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

Dec 2012Nov 2013

First posted4 Oct 2012 (estimated)
Study startDec 2012
Primary completionNov 2013
Study completionNov 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 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01699750
Sponsor's protocol ID: M-12-043 / ID11-59
Status last verified: Dec 2014
First submitted: 2 Oct 2012
Last updated: 8 Dec 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?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
ClinicalTrials.gov ID: NCT01699750
Acronym / sponsor ID: M-12-043 / ID11-59
Conditions: Myopia, Astigmatism, Refractive Error
Keywords: contact lenses, contact lens solution, myopia, astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 8 Dec 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

Study design

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

Arm	Type	Receives
Air Optix Aqua	Experimental	Device: Lotrafilcon B contact lenses, Device: OPTI-FREE® PUREMOIST® MPDS, Device: BIOTRUE®, Device: Balafilcon A contact lenses, Device: ReNu® Multiplus®Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
Acuvue Oasys	Active comparator	Device: Senofilcon A contact lenses, Device: OPTI-FREE® PUREMOIST® MPDS, Device: BIOTRUE®, Device: Balafilcon A contact lenses, Device: ReNu® Multiplus®Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each

Who may qualify

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

Key inclusion criteria (8 listed)

Read and understand the Participant Information Sheet;
Read, sign, and date the Informed Consent;
Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;

Key exclusion criteria (12 listed)

Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
Systemic or ocular allergies which might interfere with contact lens 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, AOASilicone hydrogel contact lenses, Phase 2	Device	Air Optix Aqua
Senofilcon A contact lensesAlso: ACUVUE® OASYS® with HYDRACLEAR®, AVOSilicone hydrogel contact lenses, Phase 2	Device	Acuvue Oasys
OPTI-FREE® PUREMOIST® MPDSAlso: OFPMContact lens care system, Phase 2	Device	Acuvue Oasys, Air Optix Aqua
BIOTRUE®Contact lens care system, Phase 2	Device	Acuvue Oasys, Air Optix Aqua
Balafilcon A contact lensesAlso: PureVisionSilicone hydrogel contact lenses worn for 30 days, Phase 1	Device	Acuvue Oasys, Air Optix Aqua
ReNu® Multiplus®Contact lens care system used for 30 days, Phase 1	Device	Acuvue Oasys, Air Optix Aqua

Primary outcome

Mean Ex-Vivo Total Lipid Uptake Per Lens
Time frame: Day 30
The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.

6 secondary outcomes

Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
Time frame: Day 30
LogMAR Time-Controlled Visual Acuity (TCVA)
Time frame: Day 30
Overall Comfort Measured With Visual Analog Scale (VAS)
Time frame: Day 30
Overall Dryness Measured With Visual Analog Scale (VAS)
Time frame: Day 30
Average Exposure Speed
Time frame: Day 30
Minimum Protected Area
Time frame: Day 30

Results and safety

Results posted to the registry on 8 Dec 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 Aqua	34	34
Acuvue Oasys	36	33

Primary outcome: Mean Ex-Vivo Total Lipid Uptake Per Lens

Time frame: Day 30. Geometric mean (Standard Deviation). Unit: micrograms

Measure	Air Optix Aqua n = 34	Acuvue Oasys n = 33
Value	7.198 (1.5014)	35.879 (1.8185)

Population analysed: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIR OPTIX AQUA	0 of 34 (0%)	3 of 34 (8.8%)	Not reported
ACUVUE OASYS With HYDRACLEAR	0 of 36 (0%)	7 of 36 (19.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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.

Jami Kern, PhD 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 Lotrafilcon B contact lenses, Senofilcon A contact lenses and OPTI-FREE® PUREMOIST® MPDS in people with Myopia and Astigmatism, 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 8 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 8 Dec 2014. 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 Dec 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?

Mean Ex-Vivo Total Lipid Uptake Per Lens (time frame: Day 30). 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 NCT01699750.

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 8 Dec 2014.