Visual AcuityNCT02801396

Clinical Evaluation of Investigational Contact Lenses

A study testing Etafilcon A Design 1 (Test 1) and Etafilcon A Design 2 (Test 2) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

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

Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Etafilcon A Design 1 (Test 1) and Etafilcon A Design 2 (Test 2)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteHong Kong
Study dates: 24 Apr 2016to 22 May 2016
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
Healthy volunteers accepted
Adult

Who may be able to join

Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).
The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.
The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.
Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
Subjects must self-report as being Asian race.
Subjects must self-report as having brown or black eyes.

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Subjects must be habitual lens wearer (clear or limbal ring cosmetic) . Habitual is defined as at least one (1) month of Contact Lens wear where the lenses were worn for a minimum of six (6) hours per day and a minimum of three (3) days per week.
Subjects between 18 to 39 years old must be habitual limbal ring cosmetic lens wearers or must have tried limbal ring cosmetic lens within the past two years.
Subjects must be cosmetic contact lens concept acceptors as determined by screening questionnaire.
Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigator's discretion).
Subjects must read, understand, and sign the Statement of Informed Consent.
Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
Subjects must be willing to have their eyes video recorded and photographed.

Who cannot join

Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.
Participated in any paid market research within the past 3 months.
Pregnant or breast feeding a baby.
Subjects with diabetes.
Any ocular or systemic allergies or disease which might interfere with contact lens wear.
Any systemic disease, or autoimmune disease, which might interfere with contact lens wear, at investigator's discretion.

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Using medications during and immediately preceding the study period that may interfere with current contact lens wear as determined by the investigators
Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
Any active ocular abnormalities/conditions that might interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection etc.).
Any corneal distortion, scar, or opacity affecting vision as noted by subjects or investigators during examination.
History of any corneal surgery (e.g. radial keratotomy (RK), photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK)); confirmed with topography if necessary at the investigator's discretion.
Habitual wearers of rigid gas permeable or orthokeratology lens within the past 3 months.
Current habitual contact lens modality for extended wear or conventional wear (contact lenses with a replacement schedule of 3 months to >1 year).
Participation in any pharmaceutical, medical device, or contact lens related clinical research trial within 14 days prior to study enrollment. This excludes studies that do not require product treatment/intervention.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Hong Kong Polytechnic University
Hong Hom, Kowloon

Other trials in Hong Kong

About this study

Conditions: Visual Acuity
Being tested: Etafilcon A Design 1 (Test 1), Etafilcon A Design 2 (Test 2), Etafilcon A (Control)

What participants receive

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

Etafilcon A Design 1 (Test 1)Device
Etafilcon A Design 2 (Test 2)Device
Etafilcon A (Control)Device

Study groups in NCT02801396
Study group	Role	What they receive
Group Sequence A, B, C	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)
Group Sequence B, C, A	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)
Group Sequence C, A, B	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)
Group Sequence C, B, A	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)
Group Sequence A, C, B	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)
Group Sequence B, A, C	Active comparator	Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. Receives: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A Design 2 (Test 2); Device: Etafilcon A (Control)

What is being measured

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

CLUE Handling
CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ 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 +/- 3XSD).
Measured: 30 Minutes Post Insertion
Visual Performance (LogMar)
Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.
Measured: 30 Minutes Post Insertion
Percentage of Eyes With Acceptable Mechanical Lens Fit
Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.
Measured: 30 Minutes Post Insertion
Percentage of Eyes With Acceptable Cosmetic Lens Fit
Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.
Measured: 30 Minutes Post Insertion

Timeline

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

24 Apr 201622 May 2016

First posted15 Jun 2016 (estimated)
Study start24 Apr 2016
Primary completion22 May 2016
Study completion22 May 2016

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 Visual AcuityStudies 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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02801396
Sponsor's protocol ID: CR-5759
Status last verified: Jun 2017
First submitted: 11 May 2016
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Investigational Contact Lenses
ClinicalTrials.gov ID: NCT02801396
Acronym / sponsor ID: CR-5759
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 24 Apr 2016 (actual)
Primary completion: 22 May 2016 (actual)
Study completion: 22 May 2016 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Posted 9 Jun 2017

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: None (open label)
Number of arms: 6

Arm	Type	Receives
Group Sequence A, B, C	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.
Group Sequence B, C, A	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.
Group Sequence C, A, B	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.
Group Sequence C, B, A	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.
Group Sequence A, C, B	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.
Group Sequence B, A, C	Active comparator	Device: Etafilcon A Design 1 (Test 1), Device: Etafilcon A Design 2 (Test 2), Device: Etafilcon A (Control)Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).
The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.
The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.
Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
Subjects must self-report as being Asian race.

Key exclusion criteria (15 listed)

Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.
Participated in any paid market research within the past 3 months.
Pregnant or breast feeding a baby.
Subjects with diabetes.
Any ocular or systemic allergies or disease which might interfere with contact lens wear.

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 Design 1 (Test 1)	Device	Group Sequence A, B, C, Group Sequence A, C, B, Group Sequence B, A, C, Group Sequence B, C, A, Group Sequence C, A, B, Group Sequence C, B, A
Etafilcon A Design 2 (Test 2)	Device	Group Sequence A, B, C, Group Sequence A, C, B, Group Sequence B, A, C, Group Sequence B, C, A, Group Sequence C, A, B, Group Sequence C, B, A
Etafilcon A (Control)	Device	Group Sequence A, B, C, Group Sequence A, C, B, Group Sequence B, A, C, Group Sequence B, C, A, Group Sequence C, A, B, Group Sequence C, B, A

Primary outcome

CLUE Handling
Time frame: 30 Minutes Post Insertion
CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ 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 +/- 3XSD).
Visual Performance (LogMar)
Time frame: 30 Minutes Post Insertion
Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.
Percentage of Eyes With Acceptable Mechanical Lens Fit
Time frame: 30 Minutes Post Insertion
Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.
Percentage of Eyes With Acceptable Cosmetic Lens Fit
Time frame: 30 Minutes Post Insertion
Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.

Results and safety

Results posted to the registry on 9 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test1/Test2/Control	17	17
Test1/Control/Test2	17	17
Test2/Test1/Control	17	17
Test2/Control/Test1	16	16
Control/Test1/Test2	17	16
Control/Test2/Test1	17	17

Primary outcome: CLUE Handling

Time frame: 30 Minutes Post Insertion. Mean (Standard Deviation). Unit: Units on a scale

Measure	Test1 n = 99	Test 2 n = 99	Control n = 99
Value	55.73 (20.146)	57.58 (20.109)	64.39 (19.825)

Population analysed: Subjects that completed all study visits without a major protocol deviation.

Primary outcome: Visual Performance (LogMar)

Time frame: 30 Minutes Post Insertion. Mean (Standard Deviation). Unit: LogMAR

Measure	Test1 n = 99	Test 2 n = 99	Control n = 99
Value	0.00 (0.082)	0.00 (0.082)	0.01 (0.082)

Population analysed: Subjects that completed all study visits without a major protocol deviation.

Primary outcome: Percentage of Eyes With Acceptable Mechanical Lens Fit

Time frame: 30 Minutes Post Insertion. Number. Unit: Percentage of eyes

Measure	Test1 n = 99	Test 2 n = 99	Control n = 99
Value	95	97	91

Population analysed: Subjects that completed all study visits without a major protocol deviation.

Primary outcome: Percentage of Eyes With Acceptable Cosmetic Lens Fit

Time frame: 30 Minutes Post Insertion. Number. Unit: Percentage of eyes

Measure	Test1 n = 99	Test 2 n = 99	Control n = 99
Value	99.5	99.5	99.5

Population analysed: Subjects that completed all study visits without a major protocol deviation.

Adverse events

Time frame: Throughout the duration of the study. Approximately 3 hours per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test1	0 of 100 (0%)	0 of 100 (0%)	Not reported
Test2	0 of 100 (0%)	0 of 100 (0%)	Not reported
Control	0 of 101 (0%)	0 of 101 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Etafilcon A Design 1 (Test 1) and Etafilcon A Design 2 (Test 2) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

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 13 inclusion and 15 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 11 Jul 2017. 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 Hong Kong. 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 9 Jun 2017). 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?

CLUE Handling (time frame: 30 Minutes Post Insertion). 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 NCT02801396.

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 11 Jul 2017.