Refractive ErrorCARDINALNCT01858701

Visual Performance Investigation of Two Toric Soft Contact Lenses

A study testing Lotrafilcon B toric contact lens and Comfilcon A toric contact lens in people with Refractive Error 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

The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error, Astigmatism, Myopia
What is being tested?: Lotrafilcon B toric contact lens and Comfilcon A toric contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: No sites listed yet
Study dates: May 2013to Oct 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 informed consent;
Wears toric soft contact lenses;
Can be successfully fit with study lenses within the power ranges available;
Has cylinder of ≥ -0.75 diopter in both eyes;
Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any ocular condition that would contraindicate contact lens wear;
Use of medications for which contact lens wear could be contraindicated;
Monocular (only 1 eye with functional vision) or fit with 1 lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Requires presbyopic correction;
Use of rewetting/lubricating eye-drops more than twice a day;
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

Conditions: Refractive Error, Astigmatism, Myopia, Hyperopia
Being tested: Lotrafilcon B toric contact lens, Comfilcon A toric contact lens
Keywords: myopia, hyperopia, astigmatism, contact lenses
Medical subject headings: Refractive Errors, Astigmatism, Myopia, Hyperopia

What participants receive

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

Lotrafilcon B toric contact lensDevice
Also called AIR OPTIX® for ASTIGMATISM
Commercially available, silicone hydrogel contact lens for correction of astigmatism
Comfilcon A toric contact lensDevice
Also called Biofinity® Toric
Commercially available, silicone hydrogel contact lens for correction of astigmatism

Study groups in NCT01858701
Study group	Role	What they receive
AO for Astig / Biofinity Toric	Other	Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. Receives: Device: Lotrafilcon B toric contact lens; Device: Comfilcon A toric contact lens
Biofinity Toric / AO for Astig	Other	Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. Receives: Device: Lotrafilcon B toric contact lens; Device: Comfilcon A toric contact lens

What is being measured

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

Mean Ocular Coma Score at 5mm Pupil at Day 30
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right 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.

May 2013Oct 2013

First posted21 May 2013 (estimated)
Study startMay 2013
Primary completionOct 2013
Study completionOct 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 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858701
Sponsor's protocol ID: A01335
Other IDs: P/438/13/L
Acronym: CARDINAL
Status last verified: Oct 2014
First submitted: 17 May 2013
Last updated: 22 Oct 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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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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RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Visual Performance Investigation of Two Toric Soft Contact Lenses
ClinicalTrials.gov ID: NCT01858701
Acronym / sponsor ID: CARDINAL / A01335
Conditions: Refractive Error, Astigmatism, Myopia, Hyperopia
Keywords: myopia, hyperopia, astigmatism, contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 22 Oct 2014

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 compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

Study design

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

Arm	Type	Receives
AO for Astig / Biofinity Toric	Other	Device: Lotrafilcon B toric contact lens, Device: Comfilcon A toric contact lensLotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
Biofinity Toric / AO for Astig	Other	Device: Lotrafilcon B toric contact lens, Device: Comfilcon A toric contact lensComfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.

Who may qualify

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

Key inclusion criteria (7 listed)

Sign informed consent;
Wears toric soft contact lenses;
Can be successfully fit with study lenses within the power ranges available;
Has cylinder of ≥ -0.75 diopter in both eyes;
Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;

Key exclusion criteria (8 listed)

Any ocular condition that would contraindicate contact lens wear;
Use of medications for which contact lens wear could be contraindicated;
Monocular (only 1 eye with functional vision) or fit with 1 lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Known sensitivity to the diagnostic pharmaceuticals to be used in the study;

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 toric contact lensAlso: AIR OPTIX® for ASTIGMATISMCommercially available, silicone hydrogel contact lens for correction of astigmatism	Device	AO for Astig / Biofinity Toric, Biofinity Toric / AO for Astig
Comfilcon A toric contact lensAlso: Biofinity® ToricCommercially available, silicone hydrogel contact lens for correction of astigmatism	Device	AO for Astig / Biofinity Toric, Biofinity Toric / AO for Astig

Primary outcome

Mean Ocular Coma Score at 5mm Pupil at Day 30
Time frame: Day 30
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.

Results and safety

Results posted to the registry on 22 Oct 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
AO for Astig / Biofinity Toric	20	20
Biofinity Toric / AO for Astig	20	19

Primary outcome: Mean Ocular Coma Score at 5mm Pupil at Day 30

Time frame: Day 30. Mean (Standard Deviation). Unit: micrometers

Measure	Air Optix for Astig n = 34	Biofinity Toric n = 34
Value	0.16 (0.09)	0.24 (0.11)

Population analysed: This analysis population includes all participants who completed the study.

Adverse events

Time frame: Adverse Events (AE) were collected for the duration of the study (5 months). An AE was defined as any undesirable medical occurrence which occurs in an individual participating in a clinical trial, whether or not it is considered to be trial-related.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Air Optix for Astig	0 of 37 (0%)	0 of 37 (0%)	Not reported
Biofinity Toric	0 of 38 (0%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
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.

Jessie Lemp, MS study director

Alcon Research

Lyndon Jones, PhD principal investigator

School of Optometry and Vision Science

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B toric contact lens and Comfilcon A toric contact lens in people with Refractive Error 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 7 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 22 Oct 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 22 Oct 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 Ocular Coma Score at 5mm Pupil at Day 30 (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 NCT01858701.

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 22 Oct 2014.