MyopiaNCT01839318

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

A study testing Nelfilcon A contact lenses, Omafilcon A contact lenses and Etafilcon A contact lenses in people with Myopia and Hyperopia, 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 three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed. Read more about this study

Who is it for?: Ages 18 to 44 years
Conditions the study is for: Myopia, Hyperopia, Refractive Error
What is being tested?: Nelfilcon A contact lenses, Omafilcon A contact lenses and Etafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Apr 2013to Jun 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 to 44 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Sign Informed Consent.
Adapted soft contact lens wearer.
Willing to wear contact lenses up to 12 hours and attend all study visits.
Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
Contact lens prescription within the power range specified in the protocol.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
Any use of systemic or ocular medications that would contraindicate contact lens wear.
Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
Monocular (only 1 eye with functional vision) or fit with only 1 lens.
History of herpetic keratitis, ocular surgery, or irregular cornea.
Known pregnancy.

Show all 9Show fewer

Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
Participation in any clinical study within 30 days of Visit 1.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Read the detailed description

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Conditions: Myopia, Hyperopia, Refractive Error
Being tested: Nelfilcon A contact lenses, Omafilcon A contact lenses, Etafilcon A contact lenses
Keywords: Soft contact lenses, Daily disposable contact lenses, Tear Film Break Up Time, Contact lens wettability
Medical subject headings: Myopia, Hyperopia, Refractive Errors

What participants receive

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

Nelfilcon A contact lensesDevice
Also called DAILIES® AquaComfort Plus®
Omafilcon A contact lensesDevice
Also called Proclear® 1 day
Etafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® MOIST®

Study groups in NCT01839318
Study group	Role	What they receive
DAILIES AquaComfort Plus	Experimental	Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. Receives: Device: Nelfilcon A contact lenses
1-DAY ACUVUE MOIST	Active comparator	Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. Receives: Device: Etafilcon A contact lenses
Proclear 1 day	Active comparator	Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours. Receives: Device: Omafilcon A contact lenses

What is being measured

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

Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.
Measured: Hour 8

Secondary outcomes (1)

Total Wettability Score
The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.
Measured: Hour 8

Timeline

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

Apr 2013Jun 2013

First posted24 Apr 2013 (estimated)
Study startApr 2013
Primary completionJun 2013
Study completionJun 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: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01839318
Sponsor's protocol ID: A01336
Status last verified: May 2014
First submitted: 22 Apr 2013
Last updated: 20 Jun 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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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
ClinicalTrials.gov ID: NCT01839318
Acronym / sponsor ID: A01336
Conditions: Myopia, Hyperopia, Refractive Error
Keywords: Soft contact lenses, Daily disposable contact lenses, Tear Film Break Up Time, Contact lens wettability
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 20 Jun 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

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
DAILIES AquaComfort Plus	Experimental	Device: Nelfilcon A contact lensesNelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
1-DAY ACUVUE MOIST	Active comparator	Device: Etafilcon A contact lensesEtafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
Proclear 1 day	Active comparator	Device: Omafilcon A contact lensesOmafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.

Who may qualify

Ages: 18 to 44 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Sign Informed Consent.
Adapted soft contact lens wearer.
Willing to wear contact lenses up to 12 hours and attend all study visits.
Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
Contact lens prescription within the power range specified in the protocol.

Key exclusion criteria (9 listed)

Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
Any use of systemic or ocular medications that would contraindicate contact lens wear.
Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
Monocular (only 1 eye with functional vision) or fit with only 1 lens.
History of herpetic keratitis, ocular surgery, or irregular cornea.

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
Nelfilcon A contact lensesAlso: DAILIES® AquaComfort Plus®	Device	DAILIES AquaComfort Plus
Omafilcon A contact lensesAlso: Proclear® 1 day	Device	Proclear 1 day
Etafilcon A contact lensesAlso: 1-DAY ACUVUE® MOIST®	Device	1-DAY ACUVUE MOIST

Primary outcome

Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
Time frame: Hour 8
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

1 secondary outcome

Total Wettability Score
Time frame: Hour 8

Results and safety

Results posted to the registry on 20 Jun 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
Sequence 1	4	4
Sequence 2	4	4
Sequence 3	5	5
Sequence 4	6	6
Sequence 5	7	7
Sequence 6	2	2

Primary outcome: Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours

Time frame: Hour 8. Mean (Standard Deviation). Unit: seconds

Measure	DAILIES AquaComfort Plus n = 27	1-DAY ACUVUE MOIST n = 26	Proclear 1 Day n = 27
Value	5.28 (5.71)	3.46 (4.52)	4.93 (6.34)

Population analysed: This analysis population includes all participants exposed to the study product with reportable values.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (2 months). This analysis group includes all enrolled participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DAILIES AquaComfort Plus	0 of 30 (0%)	0 of 30 (0%)	Not reported
1-DAY ACUVUE MOIST	0 of 30 (0%)	0 of 30 (0%)	Not reported
Proclear 1 Day	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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?

A study testing Nelfilcon A contact lenses, Omafilcon A contact lenses and Etafilcon A contact lenses in people with Myopia and Hyperopia, run by Alcon Research.

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 6 inclusion and 9 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 20 Jun 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 20 Jun 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?

Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours (time frame: Hour 8). 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 NCT01839318.

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 20 Jun 2014.