Evaluation of Astigmatic Contact Lenses

NCT ID: NCT03086447

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-05-04

Brief Summary

Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate that the investigational contact lens meets the design requirements related to corneal staining, lens fit, visual acuity and rotational performance as well as subjective comfort and handling. Subjects will wear the contact lenses for a total of 28-36 days.

Conditions

Visual Acuity

Study Design

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

Study Groups

Experimental: Participating Subjects

Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed the investigational contact lens to be worn from 28-36 days, to include a total of 5 visits.

Group Type: EXPERIMENTAL

Investigational Contact Lens

Intervention Type: DEVICE

Senofilcon C Toric

Control: Participating Subjects

Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed marketed contact lens to be worn from 28-36 days, to include a total of 5 visits.

Group Type: ACTIVE_COMPARATOR

Marketed Contact Lens

Intervention Type: DEVICE

Air Optix for Astigmatism

Interventions

Investigational Contact Lens

Senofilcon C Toric

Intervention Type: DEVICE

Marketed Contact Lens

Air Optix for Astigmatism

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1) Healthy adult males or females age ≥18-40 years of age with signed informed consent.

2) The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3) Subject must be a habitual soft toric contact lens wearer. Habitual wearer is defined as someone who wears contact lenses for at least 6 hours a day, 5 days a week for the past 30 days.

4) Subject's vertex corrected spherical component of their distance refraction must be between -1.00 to -4.75 Diopter (D) (inclusive) in each eye.

5) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC (inclusive) in each eye.

6) Subject's refractive cylinder axis must be 180±25 and 90±15 in each eye. 7) The subject must have visual acuity best correctable to 20/25 or better for each eye 8) The subject must read and sign the Informed Consent form.

Exclusion Criteria

• 1) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.

3) Any ocular medications use within the last one month. 4) Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

5) Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.

6) Habitual wearer of extended wear contact lenses. 7) Known sensitivity to Revitalens OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

9) A clinical finding or history of entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report.

10) History of binocular vision abnormality or strabismus, by self-report. 11) Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

12) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

13) Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

14) Clinically significant (grade 3 or higher) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities which would contraindicate contact lens wear.

15) Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.

16) Any active ocular infection. 17) Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

18) Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Golden Optometric Group

Whittier, California, United States

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

Edward S. Wygonik, OD

Jacksonville Beach, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

Indiana University School of Optometry

Bloomington, Indiana, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

ABQ Eye Care

Albuquerque, New Mexico, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Centers

Granville, Ohio, United States

EyeCare Professionals of Powell

Powell, Ohio, United States

Professional Vision Care, Inc

Westerville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Premier Vision

Amarillo, Texas, United States

William J Bogus, OD, FAAO

Salt Lake City, Utah, United States

Botetourt Eyecare, LLC

Salem, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CR-5871

Identifier Type: -

Identifier Source: org_study_id