The Clinical Evaluation of Two Daily Disposable Contact Lenses

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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 which have 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 worn soft 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 edema, corneal vascularization, 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 are currently taking part in any other clinical study or research.

Arm && Interventions

Group	Intervention	Description
etafilcon A/omafilcon A	etafilcon A	Period 1: etafilcon A, Period 2: omafilcon A
etafilcon A/omafilcon A	omafilcon A	Period 1: etafilcon A, Period 2: omafilcon A
omafilcon A/etafilcon A	etafilcon A	Period 1: omafilcon A, Period 2: etafilcon A
omafilcon A/omafilcon A	omafilcon A	Period 1: omafilcon A, Period 2: omafilcon A
etafilcon A/etafilcon A	etafilcon A	Period 1: etafilcon A, Period 2: etafilcon A
omafilcon A/etafilcon A	omafilcon A	Period 1: omafilcon A, Period 2: etafilcon A

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity	1 week	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Secondary Outcome Measures

Name	Time	Method
Lens Comfort	1 week	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.\>0 = comfortable, \<0 = uncomfortable