Clinical Evaluation of Two Daily Disposable Contact Lenses

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

Conditions
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Refractive Error

Intervention / Treatment
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* Device: etafilcon A
* Device: ocufilcon D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: etafilcon A / ocufilcon D<br>etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable | Device: etafilcon A<br>* daily disposable contact lens<br>Device: ocufilcon D<br>* daily disposable contact lens<br>|
| Other: oculfilcon D / etafilcon A<br>ocufilcon D contact lens worn first, etafilcon A contact lens worn second | Device: etafilcon A<br>* daily disposable contact lens<br>Device: ocufilcon D<br>* daily disposable contact lens<br>|
| Other: ocufilcon D / ocufilcon D<br>ocufilcon D contact lens worn first and second | Device: ocufilcon D<br>* daily disposable contact lens<br>|
| Other: etafilcon A / etafilcon A<br>etafilcon A contact lens worn first and second | Device: etafilcon A<br>* daily disposable contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1-week follow-up |