Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia

Treatments: Device: etafilcon A multifocal contact lens; Device: etafilcon A Contact Lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01016652

VMFL-511 (Other Identifier)

CR-4558

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 35 to 47 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 2 patient groups

etafilcon A multifocal / etafilcon A sphere

Other group

Description:

period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.

Treatment:

Device: etafilcon A Contact Lens

Device: etafilcon A multifocal contact lens

etafilcon A sphere / etafilcon A multifocal

Other group

Description:

period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.

Treatment:

Device: etafilcon A Contact Lens

Device: etafilcon A multifocal contact lens