Clinical Evaluation of Multifocal Toric Contact Lenses

Johnson & Johnson (J&J)

Status

Completed

Conditions

Visual Acuity

Treatments

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03208088

CR-5935

Details and patient eligibility

About

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Enrollment

96 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign 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. The subject must be between 40 and 70 years of age.
4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D.
5. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye
6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye
7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye
8. Subjects must own a wearable pair of spectacles if required for their distance vision
9. The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration)
10. The subject must already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".

Exclusion criteria

Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear
Pregnancy or lactation
Currently diagnosed with diabetes
Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV).
Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear
Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions
Any previous, or planned, ocular or intraocular surgery (eg, radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc)
A history of amblyopia, strabismus or binocular vision abnormality
Any ocular infection or inflammation
Any ocular abnormality that may interfere with contact lens wear
Use of any ocular medication, with the exception of rewetting drops
History of herpetic keratitis
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
Employee of clinical site (eg, Investigator, Coordinator, Technician).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

96 participants in 10 patient groups

Sequence 1

Experimental group

Description:

etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 2

Experimental group

Description:

etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 3

Experimental group

Description:

etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 4

Experimental group

Description:

etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 5

Experimental group

Description:

etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 6

Experimental group

Description:

etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 7

Experimental group

Description:

etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 8

Experimental group

Description:

etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 9

Experimental group

Description:

etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Sequence 10

Experimental group

Description:

etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator)

Treatment:

Device: etafilcon A Investigational Toric Multifocal Contact Lens

Trial documents

Study Protocol and Statistical Analysis Plan: Prot_SAP_000.pdf

Trial contacts and locations

Data sourced from clinicaltrials.gov

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