AstigmatismNCT01579045

Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

A study testing senofilcon A, etafilcon A and nelfilcon A in people with Astigmatism and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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

Primary Hypotheses: Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly . Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day . Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Astigmatism, Myopia
What is being tested?: senofilcon A, etafilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2012to Mar 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 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age range 18-60 years.
Read, understand, and sign written Statement of Informed Consent.
Appear able and willing to adhere to the instructions set forth in the clinical protocol.
Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).
Have a spherical contact lens requirement in the range -1.00 to -6.00D.

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Have astigmatism of between -0.75 and -2.00DC in both eyes.
Have axes of astigmatism within +/-10° of the following available lens axes: 70°, 90°, 110°, 20°, 180° \& 160°, i.e. 60-120, 10-30 and 150-180.
Monocular distance visual acuity correctable to 6/9 or better in each eye with best sphero-cylindrical refraction.
Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Clear cornea ii) No anterior segment disorder iii) No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities) iv) No other active ocular disease or recent surgery

Who cannot join

Having worn rigid gas permeable (RGP) contact lenses within the last 30 days or polymethyl methacrylate (PMMA) contact lenses within the last 3 months.
Clinically significant corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Extended lens wear in last 3 months.
Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
Any systemic disease affecting ocular health.
Abnormal lacrimal secretions.

Show all 14Show fewer

Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial.
Any previous anterior ocular surgery.
Subjects who are known to have an infectious systemic disease (e.g.,hepatitis, tuberculosis).
Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
Subjects who are known to have diabetes.
Employees or family members of the Research site, Principal Investigator or study team.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Farnham, Surrey, GU97EN

Other trials in United Kingdom

About this study

Primary Hypotheses:

Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly .

Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day .

Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used.

Secondary Hypotheses:

Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly.

Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day.

Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.

Conditions: Astigmatism, Myopia
Being tested: senofilcon A, etafilcon A, nelfilcon A, Filcon II 3
Medical subject headings: Astigmatism, Myopia

What participants receive

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

senofilcon ADevice
bilateral daily use soft contact lens
etafilcon ADevice
bilateral daily use soft contact lens
nelfilcon ADevice
bilateral daily use soft contact lens
Filcon II 3Device
bilateral daily use soft contact lens
Filcon II 3Device
bilateral daily use soft contact lenses

Study groups in NCT01579045
Study group	Role	What they receive
Sequence 1	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 2	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 3	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 4	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 5	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 6	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 7	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 8	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 9	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 10	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 11	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, senofilcon A, Filcon II 3 Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3
Sequence 12	Experimental	Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, Filcon II 3, senofilcon A Receives: Device: senofilcon A; Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3

What is being measured

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

Lens Orientation in Recumbent Position
rotation from zero position also described as absolute value of the rotation.
Measured: up to 60 minutes in recumbent position

Secondary outcomes (1)

Monocular Visual Acuity in Recumbent Position
Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).
Measured: up to 60 minutes in recumbent position

Timeline

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

Aug 2012Mar 2013

First posted17 Apr 2012 (estimated)
Study startAug 2012
Primary completionMar 2013
Study completionMar 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 AstigmatismStudies of the same condition, open and under way.
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: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01579045
Sponsor's protocol ID: CR-005141
Status last verified: May 2015
First submitted: 13 Apr 2012
Last updated: 19 Jun 2018
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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The EYERISING Study
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P1 Toric Vs. Max 1day
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Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
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All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
ClinicalTrials.gov ID: NCT01579045
Acronym / sponsor ID: CR-005141
Conditions: Astigmatism, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 17 Apr 2012 (estimated)
Results: Posted 3 Oct 2014

Clinical summary

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

Primary Hypotheses:

Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly .

Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day .

Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used.

Secondary Hypotheses:

Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly.

Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day.

Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 12

Arm	Type	Receives
Sequence 1	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, senofilcon A, Filcon II 3
Sequence 2	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, Filcon II 3, senofilcon A
Sequence 3	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, senofilcon A, Filcon II 3
Sequence 4	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, Filcon II 3, senofilcon A
Sequence 5	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, senofilcon A, Filcon II 3
Sequence 6	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, Filcon II 3, senofilcon A
Sequence 7	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, senofilcon A, Filcon II 3
Sequence 8	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, Filcon II 3, senofilcon A
Sequence 9	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, senofilcon A, Filcon II 3
Sequence 10	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, Filcon II 3, senofilcon A
Sequence 11	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, senofilcon A, Filcon II 3
Sequence 12	Experimental	Device: senofilcon A, Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, Filcon II 3, senofilcon A

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Age range 18-60 years.
Read, understand, and sign written Statement of Informed Consent.
Appear able and willing to adhere to the instructions set forth in the clinical protocol.
Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).

Key exclusion criteria (14 listed)

Having worn rigid gas permeable (RGP) contact lenses within the last 30 days or polymethyl methacrylate (PMMA) contact lenses within the last 3 months.
Clinically significant corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Extended lens wear in last 3 months.
Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
Any systemic disease affecting ocular health.

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
senofilcon Abilateral daily use soft contact lens	Device	Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
etafilcon Abilateral daily use soft contact lens	Device	Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
nelfilcon Abilateral daily use soft contact lens	Device	Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
Filcon II 3bilateral daily use soft contact lens	Device	Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
Filcon II 3bilateral daily use soft contact lenses	Device	Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9

Primary outcome

Lens Orientation in Recumbent Position
Time frame: up to 60 minutes in recumbent position
rotation from zero position also described as absolute value of the rotation.

1 secondary outcome

Monocular Visual Acuity in Recumbent Position
Time frame: up to 60 minutes in recumbent position

Results and safety

Results posted to the registry on 3 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
All Subjects	24	24

Primary outcome: Lens Orientation in Recumbent Position

Time frame: up to 60 minutes in recumbent position. Least squares mean (95% Confidence Interval). Unit: degrees

Measure	Senofilcon A (AOfA) n = 24	Filcon II 3 (Sauflon) n = 24	Etafilcon A (1DAMfA) n = 24	Filcon II 3 (C1DT) n = 24	Nelfilcon A (FDT) n = 24
Value	15.8 (11.23 to 20.44)	35.2 (30.62 to 39.79)	19.4 (14.60 to 24.22)	29.1 (24.23 to 33.95)	21.7 (16.86 to 26.48)

Population analysed: Subjects analyzed were those enrolled, randomized, and whom completed the study.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A (AOfA)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Filcon II 3 (Sauflon)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Etafilcon A (1DAMfA)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Filcon II 3 (C1DT)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Nelfilcon A (FDT)	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

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The EYERISING Study
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A, etafilcon A and nelfilcon A in people with Astigmatism and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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 11 inclusion and 14 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 19 Jun 2018. 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 United Kingdom. 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 3 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?

Lens Orientation in Recumbent Position (time frame: up to 60 minutes in recumbent position). 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 NCT01579045.

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 19 Jun 2018.