Assessment of Daily Disposable Silicone Hydrogel Lens Wear

NCT ID: NCT01093625

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-04-30

Brief Summary

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Narafilcon B Contact Lens

Investigational Silicone Hydrogel Contact Lens

Group Type: EXPERIMENTAL

Narafilcon B Contact Lens

Intervention Type: DEVICE

Spectacles

Group Type: ACTIVE_COMPARATOR

Spectacles

Intervention Type: DEVICE

spectacle wearers

Interventions

Narafilcon B Contact Lens

Intervention Type: DEVICE

Spectacles

spectacle wearers

Intervention Type: DEVICE

Other Intervention Names

Investigational Silicone Hydrogel

Eligibility Criteria

Inclusion Criteria

• Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
• Willing to comply with the study visit schedule.
• Ages 15 to 39.
• Has access to a cellular telephone with text messaging capabilities.
• Has a current pair of spectacles.
• 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
• Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
• Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
• Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
• They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria

• Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
• Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
• Systemic disease, which might interfere with contact lens wear.
• Medication usage that may be associated with eye dryness.
• Use of any topical medication such as eye drops or ointment.
• Pregnant or lactating (by self-report).
• Aphakia.
• Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
• Have participated in any other clinical trial or research in the two weeks prior to starting this study.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CR-0916

Identifier Type: -

Identifier Source: org_study_id