Dispensing Evaluation of Investigational Contact Lenses

NCT ID: NCT02625220

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-11-30

Brief Summary

Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prototype toric lens senofilcon A

Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality.

Group Type: EXPERIMENTAL

Prototype toric lens senofilcon A

Intervention Type: DEVICE

Investigational prototype

Interventions

Prototype toric lens senofilcon A

Investigational prototype

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
• The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
• Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
• Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
• Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
• If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
• Subject's best corrected distance acuity must be 20/25-2 or better in each eye.

Exclusion Criteria

• Females who are currently pregnant or lactating.
• Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
• Habitual wearer of extended wear contact lenses.
• Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
• History of seizures.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
• History of binocular vision abnormality or strabismus, by self-report.
• Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
• Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
• Any active ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Edward S. Wygonik, OD

Jacksonville, Florida, United States

The Eye Center

Pembroke Pines, Florida, United States

Eye Associates of Winter Park

Winter Park, Florida, United States

Eyecare Associates

Bloomington, Illinois, United States

Indiana University College of Optometry

Bloomington, Indiana, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

ABQ Eyecare

Albuquerque, New Mexico, United States

Sacco Eye Group

Vestal, New York, United States

New Image Eye Center

Springfield, Ohio, United States

Professional Vision Care

Westerville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Total Eye Care PA

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

CR-5769

Identifier Type: -

Identifier Source: org_study_id