MyopiaNCT02100410

On-Eye Evaluation of Contact Lens Axis Location

A study testing Delefilcon A toric contact lens T1, Delefilcon A toric contact lens T2 and Delefilcon A toric contact lens T3 in people with Myopia and Astigmatism, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism, Refractive Error
What is being tested?: Delefilcon A toric contact lens T1, Delefilcon A toric contact lens T2 and Delefilcon A toric contact lens T3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Apr 2013to Apr 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

Sign written Informed Consent.
Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
Other protocol-defined inclusion criteria may apply.

Who cannot join

History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
History of herpetic keratitis.
Slit-lamp findings at baseline as specified in the protocol.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
Clinically significant dry eye not responding to treatment.
History of refractive surgery.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Conditions: Myopia, Astigmatism, Refractive Error
Being tested: Delefilcon A toric contact lens T1, Delefilcon A toric contact lens T2, Delefilcon A toric contact lens T3, Delefilcon A toric contact lens T4, Delefilcon A toric contact lens T5
Keywords: Contact Lens, Toric
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.

Delefilcon A toric contact lens T1Device
Iteration 2-87-1 with embossed mark
Delefilcon A toric contact lens T2Device
Iteration 2-87-1 without embossed mark
Delefilcon A toric contact lens T3Device
Iteration 2-87-2 with embossed mark
Delefilcon A toric contact lens T4Device
Iteration 2-87-2 without embossed mark
Delefilcon A toric contact lens T5Device
Iteration 2-87-3 with embossed mark
Delefilcon A toric contact lens T6Device
Iteration 2-87-3 without embossed mark

Study groups in NCT02100410
Study group	Role	What they receive
Iteration 2-87-1	Experimental	Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes Receives: Device: Delefilcon A toric contact lens T1; Device: Delefilcon A toric contact lens T2
Iteration 2-87-2	Experimental	Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes Receives: Device: Delefilcon A toric contact lens T3; Device: Delefilcon A toric contact lens T4
Iteration 2-87-3	Experimental	Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes Receives: Device: Delefilcon A toric contact lens T5; Device: Delefilcon A toric contact lens T6

What is being measured

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

Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).
Measured: Day 1

Secondary outcomes (2)

Lens Awareness
Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.
Measured: Day 1
Handling on Removal
Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).
Measured: Day 1

Timeline

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

Apr 2013Apr 2013

First posted1 Apr 2014 (estimated)
Study startApr 2013
Primary completionApr 2013
Study completionApr 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: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100410
Sponsor's protocol ID: C-12-061
Status last verified: Apr 2014
First submitted: 27 Mar 2014
Last updated: 16 May 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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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: On-Eye Evaluation of Contact Lens Axis Location
ClinicalTrials.gov ID: NCT02100410
Acronym / sponsor ID: C-12-061
Conditions: Myopia, Astigmatism, Refractive Error
Keywords: Contact Lens, Toric
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 1 Apr 2014 (estimated)
Results: Posted 16 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Iteration 2-87-1	Experimental	Device: Delefilcon A toric contact lens T1, Device: Delefilcon A toric contact lens T2Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes
Iteration 2-87-2	Experimental	Device: Delefilcon A toric contact lens T3, Device: Delefilcon A toric contact lens T4Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes
Iteration 2-87-3	Experimental	Device: Delefilcon A toric contact lens T5, Device: Delefilcon A toric contact lens T6Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes

Who may qualify

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

Key inclusion criteria (3 listed)

Sign written Informed Consent.
Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (8 listed)

History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
History of herpetic keratitis.
Slit-lamp findings at baseline as specified in the protocol.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during 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
Delefilcon A toric contact lens T1Iteration 2-87-1 with embossed mark	Device	Iteration 2-87-1
Delefilcon A toric contact lens T2Iteration 2-87-1 without embossed mark	Device	Iteration 2-87-1
Delefilcon A toric contact lens T3Iteration 2-87-2 with embossed mark	Device	Iteration 2-87-2
Delefilcon A toric contact lens T4Iteration 2-87-2 without embossed mark	Device	Iteration 2-87-2
Delefilcon A toric contact lens T5Iteration 2-87-3 with embossed mark	Device	Iteration 2-87-3
Delefilcon A toric contact lens T6Iteration 2-87-3 without embossed mark	Device	Iteration 2-87-3

Primary outcome

Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
Time frame: Day 1
Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).

2 secondary outcomes

Lens Awareness
Time frame: Day 1
Handling on Removal
Time frame: Day 1

Results and safety

Results posted to the registry on 16 May 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	8	8
Sequence 2	8	8
Sequence 3	8	8
Sequence 4	8	8
Sequence 5	8	8
Sequence 6	9	9

Primary outcome: Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear

Time frame: Day 1. Number. Unit: percentage of lenses

Measure	TEST1 n = 49	TEST3 n = 49	TEST5 n = 49
Value	24.5	46.9	36.7

Population analysed: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (18 days). This analysis group includes all participants/eyes exposed to the investigational products (embossed or non-embossed lenses).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TEST (1,3,5)	0 of 49 (0%)	0 of 49 (0%)	Not reported
TEST (2,4,6)	0 of 49 (0%)	0 of 49 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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
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.

Joachim Nick, Dipl. Ing. study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A toric contact lens T1, Delefilcon A toric contact lens T2 and Delefilcon A toric contact lens T3 in people with Myopia and Astigmatism, 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 3 inclusion and 8 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 16 May 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 16 May 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?

Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear (time frame: Day 1). 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 NCT02100410.

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 16 May 2014.