Refractive AmetropiaNCT01484054

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

A study testing etafilcon A with print and PVP for dark eyes (EAPVPDE) in people with Refractive Ametropia, 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

To evaluate and compare the performance of a new contact lens to a marketed contact lens. Read more about this study

Who is it for?: Ages 18 to 34 years, women only
Conditions the study is for: Refractive Ametropia
What is being tested?: etafilcon A with print and PVP for dark eyes (EAPVPDE)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 6 sitesUnited States
Study dates: Nov 2011to Feb 2012
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 34 years
Women only
No healthy volunteers
Adult

Who may be able to join

The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.

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Any cylinder power must be:<=0.75D.
The subject must have visual acuity best correctable to 20/25 or better for each eye.
The subject must have normal eyes (no ocular medications or ocular infection of any type).
The subject must read and sign the Statement of Informed Consent.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Who cannot join

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which 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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Any color deficiencies (color blindness) - to the best of the subject's knowledge.
Pregnancy or lactation.
Diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Subject presents with one dark iris color and one light iris color
Subject has heterochromia iridis (a difference in color between parts of one iris)
The subject is an employee or family member of the clinical study site.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Bloomfield, Connecticut, 06002
Study site
Jamestown, New York, 14750
Study site
Kingston, Pennsylvania, 18704
Study site
Moon Township, Pennsylvania, 15108
Study site
Overland Park, Kansas, 66207
Study site
Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Conditions: Refractive Ametropia
Being tested: etafilcon A with print and PVP for dark eyes (EAPVPDE), etafilcon A control lens (EADE)

What participants receive

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

etafilcon A with print and PVP for dark eyes (EAPVPDE)Device
A daily disposable contact lens
etafilcon A control lens (EADE)Device
A marketed daily disposable contact lens

Study groups in NCT01484054
Study group	Role	What they receive
EAPVPDE/EADE	Other	etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A with print and PVP for dark eyes (EAPVPDE); Device: etafilcon A control lens (EADE)
EADE/EAPVPDE	Other	etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A with print and PVP for dark eyes (EAPVPDE); Device: etafilcon A control lens (EADE)

What is being measured

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

Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range from 0-120.
Measured: After 7 to 9 days of lens wear
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.
Measured: After 7 to 9 days of lens wear
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.
Measured: After 7 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.

Nov 2011Feb 2012

First posted2 Dec 2011 (estimated)
Study startNov 2011
Primary completionFeb 2012
Study completionFeb 2012

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 AmetropiaStudies 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: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484054
Sponsor's protocol ID: CR-005128
Status last verified: May 2015
First submitted: 30 Nov 2011
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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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 Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes
ClinicalTrials.gov ID: NCT01484054
Acronym / sponsor ID: CR-005128
Conditions: Refractive Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 2 Dec 2011 (estimated)
Results: Posted 20 Jan 2014

Clinical summary

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

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EAPVPDE/EADE	Other	Device: etafilcon A with print and PVP for dark eyes (EAPVPDE), Device: etafilcon A control lens (EADE)etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
EADE/EAPVPDE	Other	Device: etafilcon A with print and PVP for dark eyes (EAPVPDE), Device: etafilcon A control lens (EADE)etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.

Who may qualify

Ages: 18 to 34 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.

Key exclusion criteria (14 listed)

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which 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 with print and PVP for dark eyes (EAPVPDE)A daily disposable contact lens	Device	EADE/EAPVPDE, EAPVPDE/EADE
etafilcon A control lens (EADE)A marketed daily disposable contact lens	Device	EADE/EAPVPDE, EAPVPDE/EADE

Primary outcome

Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
Time frame: After 7 to 9 days of lens wear
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range from 0-120.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
Time frame: After 7 to 9 days of lens wear
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
Time frame: After 7 to 9 days of lens wear
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0-120.

Results and safety

Results posted to the registry on 20 Jan 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
EAPVPDE/EADE	50	50
EADE/EAPVPDE	50	49

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

Time frame: After 7 to 9 days of lens wear. Least squares mean (Standard Error). Unit: units on a scale

Measure	EAPVPDE n = 92	EADE n = 92
Value	54.06 (2.538)	53.06 (2.537)

EAPVPDE vs EADE: Least square mean difference: 1.00 (95% CI -3.20 to 5.20), Mixed Models Analysis

Population analysed: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

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

Time frame: After 7 to 9 days of lens wear. Least squares mean (Standard Error). Unit: units on a scale

Measure	EAPVPDE n = 92	EADE n = 92
Value	53.61 (2.201)	48.91 (2.197)

EAPVPDE vs EADE: Least square mean difference: 4.70 (95% CI -0.79 to 10.19), Mixed Models Analysis

Population analysed: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

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

Time frame: After 7 to 9 days of lens wear. Least squares mean (Standard Error). Unit: units on a scale

Measure	EAPVPDE n = 92	EADE n = 92
Value	61.21 (1.847)	51.77 (1.842)

EAPVPDE vs EADE: Least square mean difference: 9.44 (95% CI 5.81 to 13.07), Mixed Models Analysis

Population analysed: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

Adverse events

Time frame: Adverse events were recorded when the subjects were exposed to the Investigational lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EAPVPDE	0 of 100 (0%)	0 of 100 (0%)	Not reported
EADE	0 of 100 (0%)	0 of 100 (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.

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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.

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 with print and PVP for dark eyes (EAPVPDE) in people with Refractive Ametropia, 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 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 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 20 Jan 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?

Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire (time frame: After 7 to 9 days of lens wear). The study lists 3 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 NCT01484054.

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.