Tear Film CharacteristicsNCT02760810

Clinical Evaluation of An Approved Contact Lens

A study testing Marketed Contact Lens in people with Tear Film Characteristics, 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 an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Tear Film Characteristics
What is being tested?: Marketed Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Apr 2016to 26 Apr 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 45 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 and 45 years of age.
The subject must have a valid spectacle prescription with expiration date not over 1 year.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.
The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.

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The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.
Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.
The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.
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.
Use of any medication with known tear film effects within 2 weeks prior to and during the study.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

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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 infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
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.
Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Aston University
Birmingham, West Midlands, B4 7ET

Other trials in United Kingdom

About this study

Conditions: Tear Film Characteristics
Being tested: Marketed Contact Lens

What participants receive

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

Marketed Contact LensDevice
Narafilcon A

Study groups in NCT02760810
Study group	Role	What they receive
narafilcon A	Experimental	Subjects who are new contact lens wearers (neophytes) between the ages of 18-45 will be dispensed the Test Lens and evaluated over a period of 2 weeks. Receives: Device: Marketed Contact Lens

What is being measured

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

Tear Film Osmolarity
Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing
Measured: 2-Week Follow-up

Secondary outcomes (2)

Tear Film Osmolarity
Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.
Measured: 1-Week Follow-up
Tear Film PH
Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.
Measured: 1-Week Follow-up

Timeline

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

12 Apr 201626 Apr 2016

First posted4 May 2016 (estimated)
Study start12 Apr 2016
Primary completion26 Apr 2016
Study completion26 Apr 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 Tear Film CharacteristicsStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02760810
Sponsor's protocol ID: CR-5815
Status last verified: Jun 2017
First submitted: 2 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
Individual data sharing: No

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 An Approved Contact Lens
ClinicalTrials.gov ID: NCT02760810
Acronym / sponsor ID: CR-5815
Conditions: Tear Film Characteristics
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 12 Apr 2016 (actual)
Primary completion: 26 Apr 2016 (actual)
Study completion: 26 Apr 2016 (actual)
First posted: 4 May 2016 (estimated)
Results: Posted 11 Jul 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
narafilcon A	Experimental	Device: Marketed Contact LensSubjects who are new contact lens wearers (neophytes) between the ages of 18-45 will be dispensed the Test Lens and evaluated over a period of 2 weeks.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 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 and 45 years of age.
The subject must have a valid spectacle prescription with expiration date not over 1 year.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.

Key exclusion criteria (12 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.
Use of any medication with known tear film effects within 2 weeks prior to and during the study.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..

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
Marketed Contact LensNarafilcon A	Device	narafilcon A

Primary outcome

Tear Film Osmolarity
Time frame: 2-Week Follow-up
Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing

2 secondary outcomes

Tear Film Osmolarity
Time frame: 1-Week Follow-up
Tear Film PH
Time frame: 1-Week Follow-up

Results and safety

Results posted to the registry on 11 Jul 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
Narafilcon A	30	29

Primary outcome: Tear Film Osmolarity

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: mOsm/L

Measure	Narafilcon A n = 27
Value	293.4 (9.50)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately 2-weeks per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Narafilcon A	0 of 30 (0%)	0 of 30 (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.
Individual participant dataSharing planned: No

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 Marketed Contact Lens in people with Tear Film Characteristics, 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 10 inclusion and 12 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 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 11 Jul 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?

Tear Film Osmolarity (time frame: 2-Week Follow-up). 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 NCT02760810.

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.