Evaluation of Astigmatic Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Investigational Contact Lens; Device: Marketed Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086447

CR-5871

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

  2. 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.

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

  4. 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.).

  5. 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.

  6. 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.

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

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

  9. 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.

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

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

267 participants in 2 patient groups

Experimental: Participating Subjects

Experimental group

Description:

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.

Treatment:

Device: Investigational Contact Lens

Control: Participating Subjects

Active Comparator group

Description:

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.

Treatment:

Device: Marketed Contact Lens