Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

Official Title
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Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study

Conditions
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Myopia

Intervention / Treatment
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* Device: etafilcon A
* Device: omafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age and no more than 39 years of age Existing soft contact lens wearers Willing to signed a written Informed Consent. Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day. Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes. Have an Astigmatism of 1.00D or less in both eyes. Require a visual correction in both eyes. Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease that would preclude lens wear. Exclusion Criteria: Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear. Clinically significant corneal staining (Grade 3 in more than one region). Keratoconus or other corneal irregularity. Abnormal lachrymal secretions. Extended wear of contact lenses last 3 months. Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks. Refractive surgery. Eye injury/surgery within 8 weeks immediately prior to enrollment for this study. Pre-existing ocular irritation that would preclude contact lens fitting. Require concurrent ocular medication Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV). Diabetes. Pregnant, lactating or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial or in last 30 days.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: etafilcon A/omafilcon A<br>etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily | Device: etafilcon A<br>* 1-day soft contact lens<br>Device: omafilcon A<br>* 1-day soft contact lens<br>|
| Active Comparator: omafilcon A/etafilcon A<br>omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily. | Device: etafilcon A<br>* 1-day soft contact lens<br>Device: omafilcon A<br>* 1-day soft contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Rating of Comfort | This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear | 
| Vision Quality | This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear | 
| Subjective Rating of Handling | This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear | 
| Corneal Staining | Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. | after 1 week of lens wear | 
| Subjective Rating of Quality Perceptions | This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear | 
| Limbal Hyperemia | This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe. | after 1 week of wear |