Visual AcuityNCT03782571

Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

A study testing etafilcon a Test 1, etafilcon A Test 2 and etafilcon A Test 3 in people with Visual Acuity, 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

This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: etafilcon a Test 1, etafilcon A Test 2 and etafilcon A Test 3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited Kingdom
Study dates: 16 Nov 2018to 25 Mar 2019
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
Healthy volunteers accepted
Adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 18 and 40 (inclusive) years of age at the time of screening.
The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report.

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The subject must agree not to participate in other clinical research for the duration of this study.
The subject's refractive cylinder must be <-1.25DC in each eye.
The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or breast feeding (self-reported).
Any systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the Investigator's discretion).
Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.
Any history of anaphylaxis or severe allergy.
Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)

Show all 9Show fewer

Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
They have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of < Grade 3 which in the investigator's opinion would contraindicate contact lens wear.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

Conditions: Visual Acuity
Being tested: etafilcon a Test 1, etafilcon A Test 2, etafilcon A Test 3, Control

What participants receive

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

etafilcon a Test 1Device
1-DAY ACUVUE® MOIST
etafilcon A Test 2Device
1-DAY ACUVUE® MOIST for ASTIGMATISM
etafilcon A Test 3Device
1-DAY ACUVUE® MOIST MULTIFOCAL
ControlOther
Bare Eye

Study groups in NCT03782571
Study group	Role	What they receive
Test1/Test2/Control/Test3	Experimental	Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. Receives: Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control
Test2/Test3/Test1/Control	Experimental	Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. Receives: Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control
Test3/Control/Test2/Test1	Experimental	Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. Receives: Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control
Control/Test1/Test3/Test2	Experimental	Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. Receives: Device: etafilcon a Test 1; Device: etafilcon A Test 2; Device: etafilcon A Test 3; Other: Control

What is being measured

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

Microsphere Clearance Rate
The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.
Measured: Post microsphere application over a 30 minute period
Microsphere Uptake Rate
The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.
Measured: Post microsphere application over a 10 minute period

Secondary outcomes (4)

Lens Movement
Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.
Measured: Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)
Corneal Curvature
Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.
Measured: Baseline
Corneal Curvature
Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.
Measured: Baseline
Blink Rate
Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.
Measured: Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.

Timeline

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

16 Nov 201825 Mar 2019

First posted20 Dec 2018
Study start16 Nov 2018
Primary completion25 Mar 2019
Study completion25 Mar 2019

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: Single blind
Who is masked: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03782571
Sponsor's protocol ID: CR-6291
Status last verified: Apr 2020
First submitted: 15 Nov 2018
Last updated: 12 May 2020
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 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
ClinicalTrials.gov ID: NCT03782571
Acronym / sponsor ID: CR-6291
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 16 Nov 2018 (actual)
Primary completion: 25 Mar 2019 (actual)
Study completion: 25 Mar 2019 (actual)
First posted: 20 Dec 2018 (actual)
Results: Posted 12 May 2020

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: 4

Arm	Type	Receives
Test1/Test2/Control/Test3	Experimental	Device: etafilcon a Test 1, Device: etafilcon A Test 2, Device: etafilcon A Test 3, Other: ControlSubjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Test2/Test3/Test1/Control	Experimental	Device: etafilcon a Test 1, Device: etafilcon A Test 2, Device: etafilcon A Test 3, Other: ControlSubjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Test3/Control/Test2/Test1	Experimental	Device: etafilcon a Test 1, Device: etafilcon A Test 2, Device: etafilcon A Test 3, Other: ControlSubjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Control/Test1/Test3/Test2	Experimental	Device: etafilcon a Test 1, Device: etafilcon A Test 2, Device: etafilcon A Test 3, Other: ControlSubjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (9 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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 Test 11-DAY ACUVUE® MOIST	Device	Control/Test1/Test3/Test2, Test1/Test2/Control/Test3, Test2/Test3/Test1/Control, Test3/Control/Test2/Test1
etafilcon A Test 21-DAY ACUVUE® MOIST for ASTIGMATISM	Device	Control/Test1/Test3/Test2, Test1/Test2/Control/Test3, Test2/Test3/Test1/Control, Test3/Control/Test2/Test1
etafilcon A Test 31-DAY ACUVUE® MOIST MULTIFOCAL	Device	Control/Test1/Test3/Test2, Test1/Test2/Control/Test3, Test2/Test3/Test1/Control, Test3/Control/Test2/Test1
ControlBare Eye	Other	Control/Test1/Test3/Test2, Test1/Test2/Control/Test3, Test2/Test3/Test1/Control, Test3/Control/Test2/Test1

Primary outcome

Microsphere Clearance Rate
Time frame: Post microsphere application over a 30 minute period
The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.
Microsphere Uptake Rate
Time frame: Post microsphere application over a 10 minute period
The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.

4 secondary outcomes

Lens Movement
Time frame: Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)
Corneal Curvature
Time frame: Baseline
Corneal Curvature
Time frame: Baseline
Blink Rate
Time frame: Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.

Results and safety

Results posted to the registry on 12 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test 1\Control\Test 2\Test 3	6	5
Test 2\Test 1\Test 3\Control	6	6
Control\Test 3\Test 1\Test 2	6	6
Test 3\Test 2\Control\Test 1	7	7

Primary outcome: Microsphere Clearance Rate

Time frame: Post microsphere application over a 30 minute period. Mean (Standard Deviation). Unit: percent clearance

Measure	Test 1 n = 7	Test 2 n = 7	Test 3 n = 7	Control (Bare Eye) n = 7
Value	96.9 (1.16)	98.1 (2.66)	99.4 (3.67)	96.6 (2.68)

Test 1 vs Control (Bare Eye): Mean Difference (Final Values): 1.7 (99.1% CI -4.0 to 7.4), Mixed Models Analysis
Test 2 vs Control (Bare Eye): Mean Difference (Final Values): 4.7 (99.1% CI -4.0 to 13.4), Mixed Models Analysis
Test 3 vs Control (Bare Eye): Mean Difference (Final Values): 8.2 (99.1% CI -2.7 to 19.1), Mixed Models Analysis

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol

Primary outcome: Microsphere Uptake Rate

Time frame: Post microsphere application over a 10 minute period. Mean (Standard Deviation). Unit: percent uptake

Measure	Test 1 n = 7	Test 2 n = 7	Test 3 n = 7	Control (Bare Eye) n = 7
Value	8.5 (4.09)	6.8 (5.31)	2.9 (3.35)	1.5 (7.62)

Test 1 vs Control (Bare Eye): Mean Difference (Final Values): 8.4 (99.1% CI -1.0 to 17.8), Mixed Models Analysis
Test 2 vs Control (Bare Eye): Mean Difference (Final Values): 6.6 (99.1% CI -7.8 to 20.9), Mixed Models Analysis
Test 3 vs Control (Bare Eye): Mean Difference (Final Values): 2.9 (99.1% CI -15.1 to 20.9), Mixed Models Analysis

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately 13 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Test 2	1 of 25 (4%)	0 of 25 (0%)	0 of 25
Test 3	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Control (Bare Eye)	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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 Test 1, etafilcon A Test 2 and etafilcon A Test 3 in people with Visual Acuity, 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 9 inclusion and 9 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 12 May 2020. 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 12 May 2020). 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?

Microsphere Clearance Rate (time frame: Post microsphere application over a 30 minute period). The study lists 2 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 NCT03782571.

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 12 May 2020.