Refractive ErrorNCT02055404

On-Eye Evaluation of Contact Lens Rotation Marks

A study testing Delefilcon A spherical contact lens with molded marks and Etafilcon A toric contact lens in people with Refractive Error, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Refractive Error
What is being tested?: Delefilcon A spherical contact lens with molded marks and Etafilcon A toric contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: No sites listed yet
Study dates: Feb 2013to Feb 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sign Informed Consent document.
Best corrected distance visual acuity (VA) 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 study enrollment.
Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
History of herpetic keratitis.
Slit-lamp findings greater than grade 2 at baseline.
Any use of systemic or ocular medications for which CL wear could be contraindicated.
Inactive corneal neovascularization greater than 1 millimeter of penetration.

Show all 10Show fewer

A clinically significant dry eye not responding to treatment.
History of refractive surgery.
Participation in a clinical study within the previous 30 days.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.

Read the detailed description

Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.

Conditions: Refractive Error
Being tested: Delefilcon A spherical contact lens with molded marks, Etafilcon A toric contact lens
Keywords: astigmatism, toric, contact lenses, daily disposable contact lenses, molded mark, rotation mark
Medical subject headings: Refractive Errors, Astigmatism

What participants receive

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

Delefilcon A spherical contact lens with molded marksDevice
Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.
Etafilcon A toric contact lensDevice
Also called 1-DAY ACUVUE® MOIST® for ASTIGMATISM
Hydrogel toric contact lens for daily wear, daily disposable use

Study groups in NCT02055404
Study group	Role	What they receive
Delefilcon A	Experimental	Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration Receives: Device: Delefilcon A spherical contact lens with molded marks
Etafilcon A	Other	Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration Receives: Device: Etafilcon A toric contact lens

What is being measured

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

Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)
Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."
Measured: Day 1

Timeline

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

Feb 2013Feb 2013

First posted5 Feb 2014 (estimated)
Study startFeb 2013
Primary completionFeb 2013
Study completionFeb 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02055404
Sponsor's protocol ID: C-12-045
Status last verified: Feb 2014
First submitted: 4 Feb 2014
Last updated: 2 Apr 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

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
Hyperopia and Myopia

All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: On-Eye Evaluation of Contact Lens Rotation Marks
ClinicalTrials.gov ID: NCT02055404
Acronym / sponsor ID: C-12-045
Conditions: Refractive Error
Keywords: astigmatism, toric, contact lenses, daily disposable contact lenses, molded mark, rotation mark
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 5 Feb 2014 (estimated)
Results: Posted 2 Apr 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 was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Delefilcon A	Experimental	Device: Delefilcon A spherical contact lens with molded marksDelefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration
Etafilcon A	Other	Device: Etafilcon A toric contact lensEtafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
History of herpetic keratitis.
Slit-lamp findings greater than grade 2 at baseline.
Any use of systemic or ocular medications for which CL wear could be contraindicated.

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 spherical contact lens with molded marksSilicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.	Device	Delefilcon A
Etafilcon A toric contact lensAlso: 1-DAY ACUVUE® MOIST® for ASTIGMATISMHydrogel toric contact lens for daily wear, daily disposable use	Device	Etafilcon A

Primary outcome

Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)
Time frame: Day 1
Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."

Results and safety

Results posted to the registry on 2 Apr 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
Overall Study	3	3

Primary outcome: Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)

Time frame: Day 1. Number. Unit: Percentage of assessments

Measure	S1 Mark n = 3	S2 Mark n = 3	S3 Mark n = 3	S4 Mark n = 3	S5 Mark n = 3	S6 Mark n = 3	S7 Mark n = 3	S8 Mark n = 3	Control n = 3
Value	42.9	71.4	78.6	46.4	71.4	82.1	78.6	75.0	93.3

Population analysed: The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.

Adverse events

Time frame: Adverse events were collected for the duration of the study (1 day).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 3 (0%)	0 of 3 (0%)	Not reported
Etafilcon A	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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
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 spherical contact lens with molded marks and Etafilcon A toric contact lens in people with Refractive Error, 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 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 2 Apr 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 2 Apr 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?

Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) (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 NCT02055404.

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 2 Apr 2014.