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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: omafilcon A; Device: etafilcon A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01155323

CR-0926

DISP-523 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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118 participants in 2 patient groups

etafilcon A/omafilcon A

Active Comparator group

Description:

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

Treatment:

Device: omafilcon A

Device: etafilcon A

omafilcon A/etafilcon A

Active Comparator group

Description:

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.

Treatment:

Device: omafilcon A

Device: etafilcon A