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

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: etafilcon A
Device: omafilcon A

Registration Number: NCT01155323

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 118

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
omafilcon A/etafilcon A	etafilcon A	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.
omafilcon A/etafilcon A	omafilcon A	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.
etafilcon A/omafilcon A	omafilcon A	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
etafilcon A/omafilcon A	etafilcon A	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

Primary Outcome Measures

Name	Time	Method
Vision Quality	after 1 week of lens wear	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.
Subjective Rating of Handling	after 1 week of lens wear	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.
Subjective Rating of Quality Perceptions	after 1 week of lens wear	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.
Corneal Staining	after 1 week of lens wear	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.
Limbal Hyperemia	after 1 week of wear	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.
Subjective Rating of Comfort	after 1 week of lens wear	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.