AstigmatismNCT01055132

Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

A study testing Etafilcon A toric contact lens and Nelfilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.

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 determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Astigmatism
What is being tested?: Etafilcon A toric contact lens and Nelfilcon A toric contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 6 sitesUnited States
Study dates: Jan 2010to Feb 2010
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The subject must be between 18 and 40 years old.
The subject must have normal eyes.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.

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The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
The subject must be an adapted wearer of soft toric contact lenses in both eyes.
The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
Subjects must already possess a wearable pair of spectacles.

Who cannot join

Ocular or systemic allergies or disease that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

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Pregnancy or lactation
Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
Diabetes
Strabismus

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32256
Study site
Los Angeles, California, 90049
Study site
Marietta, Georgia, 30060
Study site
New York, New York, 10001
Study site
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Conditions: Astigmatism
Being tested: Etafilcon A toric contact lens, Nelfilcon A toric contact lens
Medical subject headings: Astigmatism

What participants receive

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

Etafilcon A toric contact lensDevice
contact lens to correct astigmatism
Nelfilcon A toric contact lensDevice
contact lens to correct astigmatism

Study groups in NCT01055132
Study group	Role	What they receive
Etafilcon A toric contact lens/Nelfilcon A toric	Other	Etafilcon A toric contact lens first, then nelfilcon A toric second Receives: Device: Etafilcon A toric contact lens; Device: Nelfilcon A toric contact lens
Nelfilcon A toric/ Etafilcon A toric	Other	Nelfilcon A toric contact lens first, then etafilcon A toric toric second Receives: Device: Etafilcon A toric contact lens; Device: Nelfilcon A toric contact lens

What is being measured

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

Monocular Visual Acuity on LogMAR Scale
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Measured: After 5 to 9 days of lens wear
Binocular Visual Acuity on LogMAR Scale
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Measured: After 5 to 9 days of lens wear
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Measured: After 5 to 9 days of lens wear
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Measured: After 5 to 9 days of lens wear

Timeline

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

Jan 2010Feb 2010

First posted25 Jan 2010 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionFeb 2010

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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01055132
Sponsor's protocol ID: CR-1476AG
Status last verified: May 2015
First submitted: 22 Jan 2010
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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Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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The EYERISING Study
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Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
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 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
ClinicalTrials.gov ID: NCT01055132
Acronym / sponsor ID: CR-1476AG
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 25 Jan 2010 (estimated)
Results: Posted 7 Feb 2013

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 (participant)
Number of arms: 2

Arm	Type	Receives
Etafilcon A toric contact lens/Nelfilcon A toric	Other	Device: Etafilcon A toric contact lens, Device: Nelfilcon A toric contact lensEtafilcon A toric contact lens first, then nelfilcon A toric second
Nelfilcon A toric/ Etafilcon A toric	Other	Device: Etafilcon A toric contact lens, Device: Nelfilcon A toric contact lensNelfilcon A toric contact lens first, then etafilcon A toric toric second

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

The subject must be between 18 and 40 years old.
The subject must have normal eyes.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.

Key exclusion criteria (10 listed)

Ocular or systemic allergies or disease that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
Any ocular infection.

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
Etafilcon A toric contact lenscontact lens to correct astigmatism	Device	Etafilcon A toric contact lens/Nelfilcon A toric, Nelfilcon A toric/ Etafilcon A toric
Nelfilcon A toric contact lenscontact lens to correct astigmatism	Device	Etafilcon A toric contact lens/Nelfilcon A toric, Nelfilcon A toric/ Etafilcon A toric

Primary outcome

Monocular Visual Acuity on LogMAR Scale
Time frame: After 5 to 9 days of lens wear
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Binocular Visual Acuity on LogMAR Scale
Time frame: After 5 to 9 days of lens wear
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
Time frame: After 5 to 9 days of lens wear
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
Time frame: After 5 to 9 days of lens wear
The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

Results and safety

Results posted to the registry on 7 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second	36	35
Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second	33	33

Primary outcome: Monocular Visual Acuity on LogMAR Scale

Time frame: After 5 to 9 days of lens wear. Mean (Standard Deviation). Unit: logMAR

Measure	Etafilcon A Toric (Test Lens) n = 67	Nelfilcon A Toric (Active Comparator) n = 67
Value	-0.065 (0.0777)	-0.038 (0.1057)

Etafilcon A Toric (Test Lens) vs Nelfilcon A Toric (Active Comparator): Least-square mean difference: -0.037 (95% CI -0.041 to -0.0013), linear mixed model

Population analysed: Analysis was conducted on subjects who successfully complete the study.

Primary outcome: Binocular Visual Acuity on LogMAR Scale

Time frame: After 5 to 9 days of lens wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Etafilcon A Toric (Test Lens) n = 67	Nelfilcon A Toric Lens (Active Comparator) n = 67
Value	-0.122 (0.0718)	-0.108 (0.0766)

Etafilcon A Toric (Test Lens) vs Nelfilcon A Toric Lens (Active Comparator): Least-square mean difference: -0.015 (95% CI -0.027 to -0.003), linear mixed model

Population analysed: Analysis was conducted on subjects who successfully complete the study.

Primary outcome: Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire

Time frame: After 5 to 9 days of lens wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A (Test Lens) n = 67	Nelfilcon A (Active Comparator) n = 67
Value	56.4 (9.12)	44.0 (9.34)

Etafilcon A (Test Lens) vs Nelfilcon A (Active Comparator): Least-square mean difference: 11.9 (95% CI 4.05 to 19.79), linear mixed model

Population analysed: Analysis was conducted on subjects who successfully complete the study.

Primary outcome: Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.

Time frame: After 5 to 9 days of lens wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A (Test Lens) n = 67	Nelfilcon A (Active Comparator) n = 67
Value	52.7 (8.64)	44.7 (9.41)

Etafilcon A (Test Lens) vs Nelfilcon A (Active Comparator): least-square mean difference: 7.7 (95% CI 0.58 to 14.80), linear mixed model

Population analysed: Analysis was conducted on subjects who successfully complete the study.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A Toric / Nelfilcon A Toric	0 of 69 (0%)	0 of 69 (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

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.

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Etafilcon A toric contact lens and Nelfilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.

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 10 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 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 6 sites in United States. 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 7 Feb 2013). 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?

Monocular Visual Acuity on LogMAR Scale (time frame: After 5 to 9 days of lens wear). The study lists 4 primary outcomes in all. 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 NCT01055132.

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.