Refractive ErrorNCT01163760

Clinical Evaluation of Two Daily Disposable Contact Lenses

A study testing etafilcon A and ocufilcon D in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 1 site in Singapore.

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

Who is it for?: Ages 21 to 39 years
Conditions the study is for: Refractive Error
What is being tested?: etafilcon A and ocufilcon D
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteSingapore
Study dates: Sep 2007to Sep 2007
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 21 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be between 21 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).
Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
Astigmatism of 1.00D or less in both eyes.

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Be able to wear the lens powers available for this study.
Be correctable to a visual acuity of 20/30 or better in each eye.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection.
No conjunctival abnormality or infection.
No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
No other active ocular disease.

Who cannot join

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
Extended lens wear in last 3 months.

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PMMA or RGP lens wear in the previous 8 weeks.
Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial or in last 60 days."

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Study site
Singapore

Other trials in Singapore

About this study

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Conditions: Refractive Error
Being tested: etafilcon A, ocufilcon D
Medical subject headings: Refractive Errors

What participants receive

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

etafilcon ADevice
daily disposable contact lens
ocufilcon DDevice
daily disposable contact lens

Study groups in NCT01163760
Study group	Role	What they receive
etafilcon A / ocufilcon D	Other	etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable Receives: Device: etafilcon A; Device: ocufilcon D
oculfilcon D / etafilcon A	Other	ocufilcon D contact lens worn first, etafilcon A contact lens worn second Receives: Device: etafilcon A; Device: ocufilcon D
ocufilcon D / ocufilcon D	Other	ocufilcon D contact lens worn first and second Receives: Device: ocufilcon D
etafilcon A / etafilcon A	Other	etafilcon A contact lens worn first and second Receives: Device: etafilcon A

What is being measured

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

Lens Comfort
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
Measured: 1-week follow-up

Secondary outcomes (1)

Comfort Throughout the Whole Day
Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
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.

Sep 2007Sep 2007

First posted16 Jul 2010 (estimated)
Study startSep 2007
Primary completionSep 2007
Study completionSep 2007

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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163760
Sponsor's protocol ID: CR-0706
Other IDs: PRO-518
Status last verified: May 2015
First submitted: 29 Sep 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
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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 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Two Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT01163760
Acronym / sponsor ID: CR-0706
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Singapore Polytechnic University, Visioncare Research Ltd.
Study start: Sep 2007
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 16 Jul 2010 (estimated)
Results: Posted 16 Jul 2010

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 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: 4

Arm	Type	Receives
etafilcon A / ocufilcon D	Other	Device: etafilcon A, Device: ocufilcon Detafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
oculfilcon D / etafilcon A	Other	Device: etafilcon A, Device: ocufilcon Docufilcon D contact lens worn first, etafilcon A contact lens worn second
ocufilcon D / ocufilcon D	Other	Device: ocufilcon Docufilcon D contact lens worn first and second
etafilcon A / etafilcon A	Other	Device: etafilcon Aetafilcon A contact lens worn first and second

Who may qualify

Ages: 21 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Be between 21 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).
Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.

Key exclusion criteria (13 listed)

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

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 Adaily disposable contact lens	Device	etafilcon A / etafilcon A, etafilcon A / ocufilcon D, oculfilcon D / etafilcon A
ocufilcon Ddaily disposable contact lens	Device	etafilcon A / ocufilcon D, ocufilcon D / ocufilcon D, oculfilcon D / etafilcon A

Primary outcome

Lens Comfort
Time frame: 1-week follow-up
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

1 secondary outcome

Comfort Throughout the Whole Day
Time frame: 1-week follow-up

Results and safety

Results posted to the registry on 16 Jul 2010, 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 First, Then Ocufilcon D	12	12
Ocufilcon D First, Then Etafilcon A	13	13
Etafilcon A First, Then Etafilcon A	13	13
Ocufilcon D First, Then Ocufilcon D	12	12

Primary outcome: Lens Comfort

Time frame: 1-week follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 51	Ocufilcon D n = 49
Value	3.08 (0.98)	3.00 (1.15)

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

1 secondary outcome is 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/ Ocufilcon D	0 of 12 (0%)	0 of 12 (0%)	Not reported
Ocufilcon D / Etafilcon A	0 of 13 (0%)	0 of 13 (0%)	Not reported
Etafilcon A/ Etafilcon A	0 of 13 (0%)	0 of 13 (0%)	Not reported
Oculfilcon D / Ocufilcon D	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): The integrity of the subject reported data is suspect and not reflective of lens' performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased.

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 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 etafilcon A and ocufilcon D in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 1 site in Singapore.

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 14 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 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 Singapore. 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 16 Jul 2010). 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?

Lens Comfort (time frame: 1-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 NCT01163760.

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.