MyopiaNCT00775021

A Clinical Comparison of Two Daily Disposable Contact Lenses.

A study testing etafilcon A and nelfilcon A in people with 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

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Myopia
What is being tested?: etafilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2008to Jan 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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age: 18 years to 45 years
Current daily soft contact lens as habitual optical correction:
Refraction:
Best sphere (corrected for back vertex distance) -1.00 to -6.00D
Cylinder 0.00 to - 0.75D
Best spectacle corrected visual acuity of 6/9 or better in each eye
Willingness to adhere to the instructions set in the clinical protocol
Signature of the subject on the informed consent form

Who cannot join

Systemic or ocular allergies which might interfere with contact lens wear
Systemic disease which might interfere with contact lens wear
Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
Use of medication which might interfere with contact lens wear
Active ocular infection
Use of ocular medication

Show all 12Show fewer

Significant ocular anomaly
Presence of two or more corneal scars in either eye
Pregnancy or lactation
Any medical condition that might be prejudicial to the study
Participated in any other clinical studies in the past month
Currently wears monovision

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Otometry Technology Group, Ltd.
London, SW1E 6AU

Other trials in United Kingdom

About this study

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Conditions: Myopia
Being tested: etafilcon A, nelfilcon A
Medical subject headings: Myopia

What participants receive

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

etafilcon ADevice
Contact Lens
nelfilcon ADevice
Contact Lens

Study groups in NCT00775021
Study group	Role	What they receive
etafilcon A/nelfilcon A	Active comparator	etafilcon A contact lens worn first and nelfilcon A contact lens worn second Receives: Device: etafilcon A; Device: nelfilcon A
nelfilcon A/etafilcon A	Active comparator	nelfilcon A contact lens worn first and etafilcon A contact lens second. Receives: Device: etafilcon A; Device: nelfilcon A

What is being measured

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

Overall Comfort
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 1 week

Secondary outcomes (4)

Inferior Region Corneal Staining
The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)
Measured: 1 week
End of the Day Comfort
Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 1 week
Initial Comfort
Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 1 Week
Overall Lens Handling
Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 1 week

Timeline

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

Aug 2008Jan 2009

First posted17 Oct 2008 (estimated)
Study startAug 2008
Primary completionJan 2009
Study completionJan 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 MyopiaStudies 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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00775021
Sponsor's protocol ID: CR-0814
Other IDs: ID08-34
Status last verified: May 2015
First submitted: 15 Oct 2008
Last updated: 19 Jun 2018
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
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Comparison of Two Daily Disposable Contact Lenses.
ClinicalTrials.gov ID: NCT00775021
Acronym / sponsor ID: CR-0814
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 17 Oct 2008 (estimated)
Results: Posted 3 Mar 2011

Clinical summary

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

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Study design

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

Arm	Type	Receives
etafilcon A/nelfilcon A	Active comparator	Device: etafilcon A, Device: nelfilcon Aetafilcon A contact lens worn first and nelfilcon A contact lens worn second
nelfilcon A/etafilcon A	Active comparator	Device: etafilcon A, Device: nelfilcon Anelfilcon A contact lens worn first and etafilcon A contact lens second.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Age: 18 years to 45 years
Current daily soft contact lens as habitual optical correction:
Refraction:
Best spectacle corrected visual acuity of 6/9 or better in each eye
Willingness to adhere to the instructions set in the clinical protocol

Key exclusion criteria (12 listed)

Systemic or ocular allergies which might interfere with contact lens wear
Systemic disease which might interfere with contact lens wear
Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
Use of medication which might interfere with contact lens wear
Active ocular infection

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 AContact Lens	Device	etafilcon A/nelfilcon A, nelfilcon A/etafilcon A
nelfilcon AContact Lens	Device	etafilcon A/nelfilcon A, nelfilcon A/etafilcon A

Primary outcome

Overall Comfort
Time frame: 1 week
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

4 secondary outcomes

Inferior Region Corneal Staining
Time frame: 1 week
End of the Day Comfort
Time frame: 1 week
Initial Comfort
Time frame: 1 Week
Overall Lens Handling
Time frame: 1 week

Results and safety

Results posted to the registry on 3 Mar 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
Etafilcon A/Nelfilcon A	63	62
Nelfilcon A/Etafilcon A	60	60

Primary outcome: Overall Comfort

Time frame: 1 week. Least squares mean (Standard Error). Unit: units on a scale

Measure	Etafilcon A n = 121	Nelfilcon A n = 121
Value	3.6685 (0.1141)	3.4352 (0.1148)

Etafilcon A: Mean Difference (Final Values): 0.2334 (95% CI -0.03501 to 0.2334), Mixed Models Analysis

Population analysed: Analysis includes all participants that completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A	0 of 122 (0%)	0 of 122 (0%)	Not reported
Nelfilcon A	0 of 122 (0%)	0 of 122 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
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 etafilcon A and nelfilcon A in people with 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 8 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 19 Jun 2018. 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 3 Mar 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?

Overall Comfort (time frame: 1 week). 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 NCT00775021.

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 19 Jun 2018.