Evaluation of Astigmatic Contact Lenses

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

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.

Key facts

Study ID

NCT03086447

Run by

Johnson & Johnson Vision Care, Inc.

People needed

267

Starts

2017-03-01

Expected to finish

2017-05-04

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1) 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…

• 1) 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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