Refractive ErrorNCT00708032

Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

A study testing spectacles and narafilcon A soft contact lenses in people with Refractive Error and Myopia, 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

Search all trials

Trial summary

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Refractive Error, Myopia
What is being tested?: spectacles and narafilcon A soft contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Jun 2008to 1 Dec 2009
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 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
They have successfully worn contact lenses within six months of starting the study.

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

Show all 11Show fewer

They are pregnant or lactating.
They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
They have diabetes.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research, The University of Manchester
Manchester, Greater Manchester, M60 1QD

Other trials in United Kingdom

About this study

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Conditions: Refractive Error, Myopia
Being tested: spectacles, narafilcon A soft contact lenses
Medical subject headings: Refractive Errors, Myopia

What participants receive

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

spectaclesDevice
habitual spectacles
narafilcon A soft contact lensesDevice
narafilcon A daily disposable contact lenses

Study groups in NCT00708032
Study group	Role	What they receive
spectacles	Other	habitual spectacles worn daily for 12 months Receives: Device: spectacles
narafilcon A soft contact lenses	Experimental	narafilcon A soft contact lenses worn as daily disposable for 12 months Receives: Device: narafilcon A soft contact lenses

What is being measured

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

Papillary Conjunctivitis
Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
Measured: 12 months

Secondary outcomes (4)

Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.
Measured: at 12 months
Visual Acuity After 12 Months of Wear
Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.
Measured: at 12 months
Subjective Overall Comfort After 12 Months of Daily Wear
subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
Measured: at 12 months
Subjective Overall Vision After 12 Months of Daily Wear
subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision
Measured: at 12 months

Timeline

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

1 Jun 20081 Dec 2009

First posted2 Jul 2008 (estimated)
Study start1 Jun 2008
Primary completion1 Dec 2009
Study completion1 Dec 2009

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 Refractive ErrorStudies 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: Single blind
Who is masked: Participant
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708032
Sponsor's protocol ID: CR-0806
Status last verified: Nov 2019
First submitted: 27 Jun 2008
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
ClinicalTrials.gov ID: NCT00708032
Acronym / sponsor ID: CR-0806
Conditions: Refractive Error, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: University of Manchester
Study start: 1 Jun 2008 (actual)
Primary completion: 1 Dec 2009 (actual)
Study completion: 1 Dec 2009 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Posted 8 Dec 2011

Clinical summary

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

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Study design

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

Arm	Type	Receives
spectacles	Other	Device: spectacleshabitual spectacles worn daily for 12 months
narafilcon A soft contact lenses	Experimental	Device: narafilcon A soft contact lensesnarafilcon A soft contact lenses worn as daily disposable for 12 months

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

Key exclusion criteria (11 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.

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
spectacleshabitual spectacles	Device	spectacles
narafilcon A soft contact lensesnarafilcon A daily disposable contact lenses	Device	narafilcon A soft contact lenses

Primary outcome

Papillary Conjunctivitis
Time frame: 12 months
Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

4 secondary outcomes

Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
Time frame: at 12 months
Visual Acuity After 12 Months of Wear
Time frame: at 12 months
Subjective Overall Comfort After 12 Months of Daily Wear
Time frame: at 12 months
Subjective Overall Vision After 12 Months of Daily Wear
Time frame: at 12 months

Results and safety

Results posted to the registry on 8 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spectacles	36	26
Narafilcon A Lenses	38	22

Primary outcome: Papillary Conjunctivitis

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Narafilcon A Lenses n = 22	Spectacles n = 26
Value	1.22 (0.21)	1.04 (0.26)

Population analysed: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the sutdy. Approximately 12 month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spectacles	0 of 36 (0%)	5 of 36 (13.9%)	0 of 36
Narafilcon A Lenses	0 of 38 (0%)	4 of 38 (10.5%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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 spectacles and narafilcon A soft contact lenses in people with Refractive Error and Myopia, 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 7 inclusion and 11 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 10 Dec 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 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 8 Dec 2011). 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?

Papillary Conjunctivitis (time frame: 12 months). 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 NCT00708032.

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 10 Dec 2019.