Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia

Treatments: Device: etafilcon A; Device: lotrafilcon B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01763047

CR-5357

Details and patient eligibility

About

The objective of this study is to evaluate the performance of a novel multifocal lens system.

Enrollment: 298 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. Subjects must be between 40 and 70 years of age.
4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
8. Subjects' should own a wearable pair of spectacles.
9. Subjects' must 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 or more duration).
10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

Exclusion criteria

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
5. 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.
6. Any ocular infection.
7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

etafilcon A/lotrafilcon B

Active Comparator group

Description:

Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.

Treatment:

Device: lotrafilcon B

Device: etafilcon A

lotrafilcon B/etafilcon A

Active Comparator group

Description:

Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.

Treatment:

Device: lotrafilcon B

Device: etafilcon A