Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Completed · Not applicable

Conditions studied: Presbyopia

In brief

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

Key facts

Study ID

NCT01016652

Run by

Johnson & Johnson Vision Care, Inc.

People needed

49

Starts

2009-10-01

Expected to finish

2009-12-01

Last updated by the study team

2018-06-19

Who can join

Age: 35 and older, up to 47. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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