AstigmatismNCT02071771

Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

A study testing Nelfilcon A toric contact lenses and Etafilcon A toric contact lenses in people with 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

The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: Nelfilcon A toric contact lenses and Etafilcon A toric contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Apr 2014to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign an Informed Consent document;
Wear toric soft contact lenses within the protocol-specified range;
Cylinder equal or higher than -0.75 diopters (D) in both eyes;
Have an acceptable fit with both study contact lenses;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
Best corrected visual acuity (BCVA) of 20/30 Snellen;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Require presbyopic correction;
Any ocular condition observed during examination at the enrollment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;

Show all 10Show fewer

Pregnant or lactating;
Participation in any clinical trial within 30 days of the enrollment visit;
Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance

Conditions: Astigmatism
Being tested: Nelfilcon A toric contact lenses, Etafilcon A toric contact lenses
Keywords: DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric
Medical subject headings: Astigmatism

What participants receive

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

Nelfilcon A toric contact lensesDevice
Also called DACP Toric, DAILIES® AQUACOMFORT PLUS® TORIC
Etafilcon A toric contact lensesDevice
Also called 1-DAY ACUVUE® MOIST® for Astigmatism

Study groups in NCT02071771
Study group	Role	What they receive
DACP T, Then 1DAM A	Other	Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. Receives: Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses
1DAM A, Then DACP T	Other	Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. Receives: Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

What is being measured

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

High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Measured: Day 10, each product

Secondary outcomes (1)

Lens Oscillation at Blink at Day 10
Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.
Measured: Day 10, each product

Timeline

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

Apr 2014Sep 2014

First posted26 Feb 2014 (estimated)
Study startApr 2014
Primary completionSep 2014
Study completionSep 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 AstigmatismStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02071771
Sponsor's protocol ID: M-14-007
Status last verified: Oct 2015
First submitted: 24 Feb 2014
Last updated: 10 Nov 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?

Official record

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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The EYERISING Study
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P1 Toric Vs. Max 1day
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Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
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All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance
ClinicalTrials.gov ID: NCT02071771
Acronym / sponsor ID: M-14-007
Conditions: Astigmatism
Keywords: DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 26 Feb 2014 (estimated)
Results: Posted 10 Nov 2015

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
DACP T, Then 1DAM A	Other	Device: Nelfilcon A toric contact lenses, Device: Etafilcon A toric contact lensesNelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
1DAM A, Then DACP T	Other	Device: Nelfilcon A toric contact lenses, Device: Etafilcon A toric contact lensesEtafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.

Who may qualify

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

Key inclusion criteria (7 listed)

Must sign an Informed Consent document;
Wear toric soft contact lenses within the protocol-specified range;
Cylinder equal or higher than -0.75 diopters (D) in both eyes;
Have an acceptable fit with both study contact lenses;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;

Key exclusion criteria (10 listed)

Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Require presbyopic correction;
Any ocular condition observed during examination at the enrollment visit;

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 toric contact lensesAlso: DACP Toric, DAILIES® AQUACOMFORT PLUS® TORIC	Device	1DAM A, Then DACP T, DACP T, Then 1DAM A
Etafilcon A toric contact lensesAlso: 1-DAY ACUVUE® MOIST® for Astigmatism	Device	1DAM A, Then DACP T, DACP T, Then 1DAM A

Primary outcome

High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
Time frame: Day 10, each product
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

1 secondary outcome

Lens Oscillation at Blink at Day 10
Time frame: Day 10, each product

Results and safety

Results posted to the registry on 10 Nov 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 T, Then 1DAM A	41	39
1DAM A, Then DACP T	39	39

Primary outcome: High Contrast Time Controlled Visual Acuity (TCVA) at Day 10

Time frame: Day 10, each product. Mean (Standard Deviation). Unit: VA units

Measure	DACP T n = 69	1DAM A n = 69
Value	0.02 (0.94)	0.04 (0.92)

Population analysed: This analysis group includes all randomized subjects who had no major protocol violations excluding those who met 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 (AEs) were collected for the duration of the study (5 months). This analysis group includes all subjects exposed to investigational product based on treatment-specific exposure, as reported by the subject or observed by the investigator.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DACP T	0 of 79 (0%)	0 of 79 (0%)	Not reported
1DAM A	0 of 78 (0%)	0 of 78 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Clinical Manager, EMEA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A toric contact lenses and Etafilcon A toric contact lenses in people with 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 7 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 10 Nov 2015. 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 10 Nov 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?

High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 (time frame: Day 10, each product). 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 NCT02071771.

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 Nov 2015.