Refractive ErrorNCT00708643

Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

A study testing Habitual Silicone Hydrogel Contact Lens and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.

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 and subjective performance of a new daily disposable soft contact lens. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Refractive Error, Myopia
What is being tested?: Habitual Silicone Hydrogel Contact Lens and narafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteCanada
Study dates: Jun 2008to Sep 2008
Phase: Interventional

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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

They are of legal age (17 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.

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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.

Canada1 site

Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Conditions: Refractive Error, Myopia
Being tested: Habitual Silicone Hydrogel Contact Lens, narafilcon A
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.

Habitual Silicone Hydrogel Contact LensDevice
contact lens
narafilcon ADevice
contact lens

Study groups in NCT00708643
Study group	Role	What they receive
Habitual silicone hydrogel	Active comparator	Habitual contact lens wear. Receives: Device: Habitual Silicone Hydrogel Contact Lens
narafilcon A	Experimental	Silicone hydrogel daily disposable contact lens Receives: Device: narafilcon A

What is being measured

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

Limbal Hyperemia
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks
Lens Comfort
Rating of lens comfort by rating agreement to the following statement:
"The lenses I am wearing are comfortable."
Rating using the following scale:
1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Measured: At 3,7,10,13,17,21,24, and 27 days
Upper Lid Margin Staining
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks.

Secondary outcomes (3)

Tarsal Roughness
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks
Tarsal Hyperemia
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Measured: At 2 weeks and 4 weeks.
Corneal Staining
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks.

Timeline

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

Jun 2008Sep 2008

First posted2 Jul 2008 (estimated)
Study startJun 2008
Primary completionSep 2008
Study completionSep 2008

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708643
Sponsor's protocol ID: CR-0803
Status last verified: May 2015
First submitted: 27 Jun 2008
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov

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?

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