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Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

NCT01016652

CompletedNA

Sponsor: Johnson & Johnson Vision Care, Inc.

Conditions: Presbyopia

Interventions: etafilcon A multifocal contact lens, etafilcon A Contact Lens

Countries: United States

The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.

Eligibility overview

Sex: ALL

Age: 35 Years to 47 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* To have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
* Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Between 35 and 47 years of age (inclusive).
* Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
* Refractive astigmatism of 0.75D or less in both eyes.
* Visual symptoms associated with near vision
* Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

1. No amblyopia.
2. No evidence of lid abnormality or infection.
3. No conjunctival abnormality or infection.
4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
5. No other active ocular disease.

Exclusion Criteria:

* Monovision user or multifocal CL wearer.
* Regular user of reading spectacles (i.e. daily usage).
* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
* Corneal staining Grade 3 in more than two regions.
* Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
* Pre-existing ocular irritation that would preclude CL fitting.
* Keratoconus or other corneal irregularity.

Locations (8)

North Little Rock, Arkansas, United States
Blue Springs, Missouri, United States
Lake Ozark, Missouri, United States
Warren, Ohio, United States
Kittanning, Pennsylvania, United States
Warwick, Rhode Island, United States
Chamberlain, South Dakota, United States
Burlington, Vermont, United States