Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

NCT ID: NCT01354223

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-04-30

Brief Summary

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Detailed Description

This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stenfilcon A contact lens

Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode

Group Type: EXPERIMENTAL

stenfilcon A contact lens

Intervention Type: DEVICE

Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode

ocufilcon B contact lens

Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode

Group Type: ACTIVE_COMPARATOR

ocufilcon B contact lens

Intervention Type: DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Interventions

stenfilcon A contact lens

Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode

Intervention Type: DEVICE

ocufilcon B contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type: DEVICE

Other Intervention Names

CooperVision ClearSight™ 1 Day

Eligibility Criteria

Inclusion Criteria

Prior to being considered eligible to participate in this study, each subject MUST:

• Be at least 18 years of age as of the date of evaluation for the study.
• Have:

• Read the Informed Consent
• been given an explanation of the Informed Consent
• indicated understanding of the Informed Consent
• signed the Informed Consent document.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
• Possess wearable and visually functional eyeglasses.
• Be in good general health, based on his/her knowledge.
• Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
• Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
• Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Exclusion Criteria

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

• Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
• Poor personal hygiene.
• Any active participation in another clinical trial within 30 days prior to this study.
• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
• A member, relative or household member of the investigator or of the investigational office staff.
• Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study.
• Previous refractive surgery; or current or previous orthokeratology treatment.
• Is aphakic or psuedophakic.
• Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
• The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
• A history of papillary conjunctivitis that has interfered with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

• Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
• Pterygium
• Corneal scars within the visual axis
• Neovascularization or ghost vessels > 1.0 mm in from the limbus
• Giant papillary conjunctivitis (GPC) of > Grade 2
• Anterior uveitis or iritis
• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Byrnes, OD

Role: PRINCIPAL_INVESTIGATOR

Lee Rigel, OD

Role: PRINCIPAL_INVESTIGATOR

Mary Jo Stiegemeier, OD

Role: PRINCIPAL_INVESTIGATOR

Peter Van Hoven, OD

Role: PRINCIPAL_INVESTIGATOR

Eric White, OD

Role: PRINCIPAL_INVESTIGATOR

Locations

Eric M. White, OD, Inc.

San Diego, California, United States

Vision Care Associates

East Lansing, Michigan, United States

Western Reserve Vision Care

Beachwood, Ohio, United States

Primary Eyecare Group, P.C.

Brentwood, Tennessee, United States

Countries

United States

Other Identifiers

FC100239

Identifier Type: -

Identifier Source: org_study_id