Refractive ErrorNCT02089191

Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

A study testing Nelfilcon A contact lenses and Stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 1 site in Germany.

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 tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear. Read more about this study

Who is it for?: Ages 18 to 44 years
Conditions the study is for: Refractive Error
What is being tested?: Nelfilcon A contact lenses and Stenfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteGermany
Study dates: Mar 2014to Apr 2014
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

Must sign an Informed Consent form;
Adapted, current soft contact lens wearer;
Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
Cylinder ≤ -1.00 D in both eyes at Visit 1;
Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
Willing to wear study lenses up to 12 hours and attend all study visits;

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Able to be successfully fitted with study lenses;
Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
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 for which contact lens wear could be contraindicated, as determined by the Investigator;
Use of artificial tears and rewetting drops during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Any abnormal ocular condition observed during Visit 1;
History of herpetic keratitis, ocular surgery, or irregular cornea;

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Pregnant or lactating;
Participation in any clinical study within 30 days of Visit 1;
Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Alcon Investigative Site
Jena

Other trials in Germany

About this study

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

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Conditions: Refractive Error
Being tested: Nelfilcon A contact lenses, Stenfilcon A contact lenses
Keywords: DACP, DAILIES® AquaComfort Plus, Tear film stability, NIK-BUT
Medical subject headings: 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®, DACP
Stenfilcon A contact lensesDevice
Also called MyDay®

Study groups in NCT02089191
Study group	Role	What they receive
DACP/MyDay	Other	Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. Receives: Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses
MyDay/DACP	Other	Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. Receives: Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses

What is being measured

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

Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.
Measured: Day 1, Hour 12, each period

Secondary outcomes (1)

Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.
Measured: Hour 12

Timeline

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

Mar 2014Apr 2014

First posted17 Mar 2014 (estimated)
Study startMar 2014
Primary completionApr 2014
Study completionApr 2014

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
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02089191
Sponsor's protocol ID: M-14-006
Status last verified: Apr 2015
First submitted: 14 Mar 2014
Last updated: 15 May 2015
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 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
ClinicalTrials.gov ID: NCT02089191
Acronym / sponsor ID: M-14-006
Conditions: Refractive Error
Keywords: DACP, DAILIES® AquaComfort Plus, Tear film stability, NIK-BUT
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 17 Mar 2014 (estimated)
Results: Posted 15 May 2015

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 is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DACP/MyDay	Other	Device: Nelfilcon A contact lenses, Device: Stenfilcon A contact lensesNelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.
MyDay/DACP	Other	Device: Nelfilcon A contact lenses, Device: Stenfilcon A contact lensesStenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Who may qualify

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

Key inclusion criteria (9 listed)

Must sign an Informed Consent form;
Adapted, current soft contact lens wearer;
Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
Cylinder ≤ -1.00 D in both eyes at Visit 1;
Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;

Key exclusion criteria (10 listed)

Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Use of artificial tears and rewetting drops during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Any abnormal ocular condition observed during 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
Nelfilcon A contact lensesAlso: DAILIES® AquaComfort Plus®, DACP	Device	DACP/MyDay, MyDay/DACP
Stenfilcon A contact lensesAlso: MyDay®	Device	DACP/MyDay, MyDay/DACP

Primary outcome

Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
Time frame: Day 1, Hour 12, each period
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.

1 secondary outcome

Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
Time frame: Hour 12

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DACP/MyDay	16	16
MyDay/DACP	15	15

Primary outcome: Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear

Time frame: Day 1, Hour 12, each period. Mean (Standard Deviation). Unit: seconds

Measure	DACP n = 31	MyDay n = 30
Value	22.84 (3.299)	22.87 (3.026)

Population analysed: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (March 2014 to April 2014). This analysis population includes all participants/eyes exposed to any investigational product evaluated in this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DACP	0 of 31 (0%)	0 of 31 (0%)	Not reported
MyDay	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): There was a high censoring rate observed with the objective measurements and therefore there are limitations to the conclusions that may be drawn.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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.

Global Medical Affairs, Clinical Manager, Vision Care 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 Nelfilcon A contact lenses and Stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 1 site in Germany.

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 9 inclusion and 10 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 15 May 2015. 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 Germany. 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 15 May 2015). 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 Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear (time frame: Day 1, Hour 12, each period). 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 NCT02089191.

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 15 May 2015.