AmetropiaNCT03556579

The Effects of Contact Lenses With Experimental Dye on Visual Function

A study testing senofilcon A with new UV blocker and senofilcon A in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 1 site 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

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Ametropia
What is being tested?: senofilcon A with new UV blocker and senofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 15 May 2018to 20 Sep 2018
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older 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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol
Between 18 and 65 (inclusive) years of age at the time of screening.
Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
The subject has a best corrected visual acuity of 20/25 or better in each eye.

Who cannot join

Currently pregnant or breastfeeding.
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Show all 13Show fewer

Multifocal, toric or extended wear contact lens correction.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any ocular infection.
Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Trial locations and contacts

1 site in 1 country.

United States1 site

Georgia Center for Sight
Statesboro, Georgia, 30642

Other trials in United States

About this study

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Conditions: Ametropia
Being tested: senofilcon A with new UV blocker, senofilcon A
Medical subject headings: Refractive Errors

What participants receive

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

senofilcon A with new UV blockerDevice
Test Lens
senofilcon ADevice
Control Lens

Study groups in NCT03556579
Study group	Role	What they receive
Test/Control	Experimental	For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again. Receives: Device: senofilcon A with new UV blocker; Device: senofilcon A
Control/Test	Experimental	For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again. Receives: Device: senofilcon A with new UV blocker; Device: senofilcon A

What is being measured

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

Two-Point Light Spread Function
The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Halos
The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Starburts
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2

Secondary outcomes (4)

Glare Disability Threshold
The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Photostress Recovery Time
Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Glare Discomfort
The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Heterochromatic Contrast Threshold
Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.
Measured: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Timeline

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

15 May 201820 Sep 2018

First posted14 Jun 2018
Study start15 May 2018
Primary completion20 Sep 2018
Study completion20 Sep 2018

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 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: Single blind
Who is masked: Participant
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03556579
Sponsor's protocol ID: CR-6100
Status last verified: Oct 2019
First submitted: 31 May 2018
Last updated: 18 Nov 2019
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 Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Contact Lenses With Experimental Dye on Visual Function
ClinicalTrials.gov ID: NCT03556579
Acronym / sponsor ID: CR-6100
Conditions: Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 15 May 2018 (actual)
Primary completion: 20 Sep 2018 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 14 Jun 2018 (actual)
Results: Posted 18 Nov 2019

Clinical summary

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

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Test/Control	Experimental	Device: senofilcon A with new UV blocker, Device: senofilcon AFor Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.
Control/Test	Experimental	Device: senofilcon A with new UV blocker, Device: senofilcon AFor Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol
Between 18 and 65 (inclusive) years of age at the time of screening.
Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.

Key exclusion criteria (13 listed)

Currently pregnant or breastfeeding.
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

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 A with new UV blockerTest Lens	Device	Control/Test, Test/Control
senofilcon AControl Lens	Device	Control/Test, Test/Control

Primary outcome

Two-Point Light Spread Function
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Halos
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Starburts
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.

4 secondary outcomes

Glare Disability Threshold
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Photostress Recovery Time
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Glare Discomfort
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Heterochromatic Contrast Threshold
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Results and safety

Results posted to the registry on 18 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OD:Test, OS:Control/ OD:Test, OS:Control	16	16
OD:Test, OS:Control/ OD:Control, OS:Test	14	14
OD:Control, OS:Test/ OD:Test, OS:Control	14	14
OD:Control, OS:Test/ OD:Control, OS:Test	16	16

Primary outcome: Two-Point Light Spread Function

Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2. Mean (Standard Deviation). Unit: mm

Measure	Testing With Additional Light Source n = 54	Control With Additional Source n = 54	Test Without Additional Light Source n = 54	Control Without Additional Light Source n = 54
with distance filter	5.36 (3.132)	6.71 (2.521)	6.47 (3.304)	7.48 (3.149)
Without Dustance Filter	2.29 (1.129)	3.37 (1.214)	3.05 (1.205)	3.78 (1.472)

Test Without Additional Light Source vs Control Without Additional Light Source: Mean Difference (Final Values): -0.68 (95% CI -1.01 to -0.36), Linear Mixed Model
Testing With Additional Light Source vs Control With Additional Source: Mean Difference (Final Values): -1.13 (95% CI -1.45 to -0.81), Linear Mixed Model Analysis

Population analysed: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.

Primary outcome: Halos

Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2. Mean (Standard Deviation). Unit: mm

Measure	Testing With Additional Light Source n = 54	Control With Additional Source n = 54	Test Without Additional Light Source n = 54	Control Without Additional Light Source n = 54
Value	29.20 (15.777)	52.57 (22.758)	39.09 (14.524)	46.73 (18.355)

Test Without Additional Light Source vs Control Without Additional Light Source: Mean Difference (Final Values): -8.86 (95% CI -13.16 to -4.55), Linear Mixed Model
Testing With Additional Light Source vs Control With Additional Source: Mean Difference (Final Values): -24.93 (95% CI -29.24 to -20.62), Linear Mixed Model Analysis

Population analysed: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.

Primary outcome: Starburts

Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2. Mean (Standard Deviation). Unit: mm

Measure	Testing With Additional Light Source n = 54	Control With Additional Source n = 54	Test Without Additional Light Source n = 54	Control Without Additional Light Source n = 54
Value	45.66 (24.228)	75.12 (27.370)	55.78 (23.037)	69.60 (25.914)

Testing With Additional Light Source vs Control With Additional Source: Mean Difference (Final Values): -30.56 (95% CI -31.66 to -25.46), Linear Mixed Model
Test Without Additional Light Source vs Control Without Additional Light Source: Mean Difference (Final Values): -15.38 (95% CI -20.48 to -10.27), Linear Mixed Model

Population analysed: Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the study. One to 14 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Control	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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 senofilcon A with new UV blocker and senofilcon A in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 7 inclusion and 13 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 18 Nov 2019. 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 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 18 Nov 2019). 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?

Two-Point Light Spread Function (time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2). 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 NCT03556579.

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 18 Nov 2019.