Visual AcuityNCT02708524

Clinical Study of Approved and Investigational Contact Lenses

A study testing Senofilcon C Contact Lens, Comfilcon A Contact Lens and Lotrafilcon B Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality. 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?: Senofilcon C Contact Lens, Comfilcon A Contact Lens and Lotrafilcon B Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 554 participants
Where: 18 sitesUnited States
Study dates: Jan 2016to Mar 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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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 to 40 years of age at the time of consent.
The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
The subject's refractive cylinder must be ≤1.00D in each eye.
The subject must have best corrected visual acuity of 20/30 or better in each eye.

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The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Who cannot join

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.

Show all 14Show fewer

Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
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.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Study site
Bloomington, Illinois
Study site
Closter, New Jersey
Study site
East Lansing, Michigan
Study site
Fruit Cove, Florida
Study site
Granville, Ohio
Study site
Jacksonville, Florida, 32256
Study site
Jacksonville, Florida
Study site
Jacksonville, Texas
Study site
Longwood, Florida
Study site
Medina, Minnesota
Study site
Montgomery, Alabama
Study site
Roanoke, Virginia
Study site
Roswell, Georgia
Study site
Salt Lake City, Utah
Study site
Tallahassee, Florida
Study site
Tampa, Florida
Study site
Vestal, New York
Study site
West Allis, Wisconsin

Other trials in United States

About this study

Conditions: Visual Acuity
Being tested: Senofilcon C Contact Lens, Comfilcon A Contact Lens, Lotrafilcon B Contact Lens, Samfilcon A Contact Lens

What participants receive

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

Senofilcon C Contact LensDevice
Also called senofilcon C
Comfilcon A Contact LensDevice
Also called comfilcon A
Lotrafilcon B Contact LensDevice
Also called lotrafilcon B
Samfilcon A Contact LensDevice
Also called samfilcon A

Study groups in NCT02708524
Study group	Role	What they receive
Senofilcon C Wearers	Experimental	Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days. Receives: Device: Senofilcon C Contact Lens
Comfilcon A Wearers	Active comparator	Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days. Receives: Device: Comfilcon A Contact Lens
Lotrafilcon B Wearers	Active comparator	Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days. Receives: Device: Lotrafilcon B Contact Lens
Samfilcon A Wearers	Active comparator	Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days. Receives: Device: Samfilcon A Contact Lens

What is being measured

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

Subjective Overall Comfort Composite Score
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Measured: Up to 1 month Follow-up
Overall Comfort Individual Item
Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: 1 month follow-up
Comfort at the End of the Day Individual Item
Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: 1 month Follow-up
Comfort Each and Everyday Individual Item
Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: 1 month Follow-up
Frequency of Lens Awareness Individual Item
Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Measured: 1 month Follow-up
Frequency of Experiencing Dryness Individual Item
Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Measured: 1 month Follow-up
Making Your Eyes Feel Moist Throughout the Day Individual Item
Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: Up to 1 month Follow-up

Secondary outcomes (3)

Subjective Overall Quality of Vision Composite Score
Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Measured: Up to 1 month Follow-up
Overall Quality of Vision Individual Item
Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: Up to 1 month Follow-up
Overall Opinion Individual Item
Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Measured: Up to 1 month Follow-up

Timeline

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

Jan 2016Mar 2016

First posted15 Mar 2016 (estimated)
Study startJan 2016
Primary completionMar 2016
Study completionMar 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708524
Sponsor's protocol ID: CR-5808
Status last verified: Sep 2016
First submitted: 3 Mar 2016
Last updated: 9 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Approved and Investigational Contact Lenses
ClinicalTrials.gov ID: NCT02708524
Acronym / sponsor ID: CR-5808
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 554 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 9 Nov 2016

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Senofilcon C Wearers	Experimental	Device: Senofilcon C Contact LensSenofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.
Comfilcon A Wearers	Active comparator	Device: Comfilcon A Contact LensComfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
Lotrafilcon B Wearers	Active comparator	Device: Lotrafilcon B Contact LensLotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.
Samfilcon A Wearers	Active comparator	Device: Samfilcon A Contact LensSamfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.

Who may qualify

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

Key inclusion criteria (9 listed)

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 to 40 years of age at the time of consent.
The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
The subject's refractive cylinder must be ≤1.00D in each eye.

Key exclusion criteria (14 listed)

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.

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 C Contact LensAlso: senofilcon C	Device	Senofilcon C Wearers
Comfilcon A Contact LensAlso: comfilcon A	Device	Comfilcon A Wearers
Lotrafilcon B Contact LensAlso: lotrafilcon B	Device	Lotrafilcon B Wearers
Samfilcon A Contact LensAlso: samfilcon A	Device	Samfilcon A Wearers

Primary outcome

Subjective Overall Comfort Composite Score
Time frame: Up to 1 month Follow-up
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Overall Comfort Individual Item
Time frame: 1 month follow-up
Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Comfort at the End of the Day Individual Item
Time frame: 1 month Follow-up
Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Comfort Each and Everyday Individual Item
Time frame: 1 month Follow-up
Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Frequency of Lens Awareness Individual Item
Time frame: 1 month Follow-up
Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Frequency of Experiencing Dryness Individual Item
Time frame: 1 month Follow-up
Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Making Your Eyes Feel Moist Throughout the Day Individual Item
Time frame: Up to 1 month Follow-up
Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

3 secondary outcomes

Subjective Overall Quality of Vision Composite Score
Time frame: Up to 1 month Follow-up
Overall Quality of Vision Individual Item
Time frame: Up to 1 month Follow-up
Overall Opinion Individual Item
Time frame: Up to 1 month Follow-up

Results and safety

Results posted to the registry on 9 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon C	139	135
Comfilcon A	136	130
Lotrafilcon B	137	134
Samfilcon A	136	136

Primary outcome: Subjective Overall Comfort Composite Score

Time frame: Up to 1 month Follow-up. Mean (Standard Deviation). Unit: average clue score

Measure	Senofilcon C n = 134	Comfilcon A n = 130	Lotrafilcon B n = 133	Samfilcon A n = 136
Baseline	65.17 (23.612)	68.58 (21.993)	66.45 (22.864)	65.46 (22.220)
Post Fit	66.65 (16.198)	62.11 (18.814)	52.27 (22.762)	64.40 (19.305)
1-Week Follow-up	67.29 (22.863)	55.78 (26.628)	54.40 (26.260)	56.96 (25.508)
2-Week Follow-up	64.18 (22.455)	55.56 (24.955)	53.09 (26.908)	55.01 (24.817)
3-Week Follow-up	61.31 (23.850)	55.01 (27.069)	52.17 (26.585)	53.72 (26.794)
4-Week Follow-up	60.74 (26.121)	56.32 (27.549)	51.15 (28.609)	52.61 (27.549)

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

Primary outcome: Overall Comfort Individual Item

Time frame: 1 month follow-up. Number. Unit: percentage of participants

Measure	Senofilcon C n = 134	Comfilcon A n = 130	Lotrafilcon B n = 133	Samfilcon A n = 136
Baseline	78	82	80	77
1-Week Follow-up	79.1	50.7	51.9	56.6
2-Week Follow-up	70.9	54.7	48.2	54.5
3-Week Follow-up	69.4	50	45.2	53
4-Week Follow-up	68.7	54.6	46.2	50

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

Primary outcome: Comfort at the End of the Day Individual Item

Time frame: 1 month Follow-up. Number. Unit: percentage of participants

Measure	Senofilcon C n = 134	Comfilcon A n = 130	Lotrafilcon B n = 133	Samfilcon A n = 136
Baseline	57.5	64.6	60.9	64.0
1-Week Follow-up	64.2	47.0	43.6	49.3
2-Week Follow-up	59.0	48.4	45.9	49.3
3-Week Follow-up	52.2	42.3	42.1	45.6
4-Week Follow-up	55.2	43.0	39.8	45.6

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

Primary outcome: Comfort Each and Everyday Individual Item

Time frame: 1 month Follow-up. Number. Unit: percentage of participants

Measure	Senofilcon C n = 134	Comfilcon A n = 130	Lotrafilcon B n = 133	Samfilcon A n = 136
Baseline	73.2	76.1	78.3	76.5
1-Week Follow-up	79.1	59.2	54.2	56.6
2-Week Follow-up	70.9	58.5	52.6	53.0
3-Week Follow-up	70.9	54.6	48.2	53.0
4-Week Follow-up	68.7	54.6	48.9	52.2

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately 1 month per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon C	0 of 139 (0%)	0 of 139 (0%)	Not reported
Comfilcon A	0 of 136 (0%)	0 of 136 (0%)	Not reported
Lotrafilcon B	0 of 137 (0%)	0 of 137 (0%)	Not reported
Samfilcon A	1 of 136 (0.7%)	0 of 136 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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.

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

Questions about this trial

What is this clinical trial studying?

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 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 9 Nov 2016). 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?

Subjective Overall Comfort Composite Score (time frame: Up to 1 month Follow-up). The study lists 7 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 NCT02708524.

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 9 Nov 2016.