Clinical Evaluation of Two Daily Disposable Contact Lenses

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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.
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.

Exclusion Criteria

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.
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."

Arm && Interventions

Group	Intervention	Description
etafilcon A / etafilcon A	etafilcon A	etafilcon A contact lens worn first and second
oculfilcon D / etafilcon A	etafilcon A	ocufilcon D contact lens worn first, etafilcon A contact lens worn second
etafilcon A / ocufilcon D	etafilcon A	etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
etafilcon A / ocufilcon D	ocufilcon D	etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
ocufilcon D / ocufilcon D	ocufilcon D	ocufilcon D contact lens worn first and second
oculfilcon D / etafilcon A	ocufilcon D	ocufilcon D contact lens worn first, etafilcon A contact lens worn second

Primary Outcome Measures

Name	Time	Method
Lens Comfort	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)

Secondary Outcome Measures

Name	Time	Method
Comfort Throughout the Whole Day	1-week follow-up	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".