CompletedInterventionalNot ApplicableUpdated Oct 31, 2012
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population | NCT00708643 | Trialant
CompletedInterventionalNot ApplicableUpdated May 21, 2015
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
ClinicalTrials.gov ID
NCT00708643
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
80Actual
Last Update Posted
May 21, 2015Estimated
Start Date
Jun 2008
Primary Completion Date
Sep 2008Actual
Completion Date
Sep 2008Actual
Brief Summary
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
Refractive Error
Myopia
Habitual Silicone Hydrogel Contact Lens
narafilcon A
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.