Evaluation of Astigmatic Contact Lenses

NCT03086447 | Completed Results FDA Device

• 1 other identifier: CR-5871
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (5)

• Monocular Distance Visual Acuity (VA)

  Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was "20/40 or better (acceptable VA)" or "worse than 20/40 (unacceptable VA)". VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.

  Up to 4-Week Follow-up

• Lens Fit Acceptance

  Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.

  15 Minutes Post Lens Fitting

• Lens Stability With Blink

  Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.

  15 Minutes Post Lens Fitting

• Absolute Lens Rotation

  Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.

  15-minutes Post Lens Insertion

• Corneal Staining

  Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.

  Up to 4-Week Follow-up

Secondary Outcomes (3)

• Overall Comfort

  Up to 4- Week Follow-up

• Overall Handling

  Up to 4- Week Follow-up

• Monocular Distance Visual Acuity (VA)

  15 Minutes Post Lens Fitting

Study Arms (2)

Experimental: Participating Subjects

EXPERIMENTAL

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.

Device: Investigational Contact Lens

Control: Participating Subjects

ACTIVE COMPARATOR

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.

Device: Marketed Contact Lens

Interventions

Investigational Contact Lens DEVICE

Senofilcon C Toric

Experimental: Participating Subjects

Marketed Contact Lens DEVICE

Air Optix for Astigmatism

Control: Participating Subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Healthy adult males or females age ≥18-40 years of age with signed informed consent.
• \) The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• \) 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.
• \) Subject's vertex corrected spherical component of their distance refraction must be between -1.00 to -4.75 Diopter (D) (inclusive) in each eye.
• \) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC (inclusive) in each eye.
• \) 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.

You may not qualify if:

• \) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
• \) 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.
• \) 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. 7) Known sensitivity to Revitalens OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• \) Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
• \) Any active ocular infection. 17) 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (17)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Dr. James Weber & Associates, PA

Jacksonville, Florida, 32205, United States

Location

Edward S. Wygonik, OD

Jacksonville Beach, Florida, 32250, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

ABQ Eye Care

Albuquerque, New Mexico, 87109, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

EyeCare Professionals of Powell

Powell, Ohio, 43065, United States

Location

Professional Vision Care, Inc

Westerville, Ohio, 43081, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Premier Vision

Amarillo, Texas, 79119, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: Kristy Canavan- SENIOR PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision

KCANAVA2@its.jnj.com

904 443-1474

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: March 1, 2017
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: July 10, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-06

Locations

US (17)