Evaluation of an Investigational Multifocal Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia

Treatments: Device: lotrafilcon B; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02223754

CR-5593

Details and patient eligibility

About

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Enrollment: 371 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 40 and 70 years of age.
4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*
7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
8. Refractive cylinder ≤ -0.75 D in each eye.
9. ADD power in the range +0.75 D to +2.50 D in each eye.
10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion criteria

1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
4. Any ocular abnormality that may have interfered with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. History of herpetic keratitis.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
13. Any ocular infection or inflammation.
14. Any corneal distortion or irregular cornea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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371 participants in 2 patient groups

lotrafilcon B / etafilcon A

Active Comparator group

Description:

Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.

Treatment:

Device: etafilcon A

Device: lotrafilcon B

etafilcon A / lotrafilcon B

Experimental group

Description:

Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.

Treatment:

Device: etafilcon A

Device: lotrafilcon B