Clinical trial NCT01016652: Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2009-11-19
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
timeFrame: week 4
measure: Monocular Amplitude of Accommodation
timeFrame: week 4
Secondary outcomes:
measure: Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
timeFrame: week 4
measure: Subject Reported Lens Comfort Using CLUE Questionnaire
timeFrame: week 4
measure: Comfortable Wearing Time
timeFrame: week 4
measure: Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
timeFrame: Baseline
Other outcomes:
Locations:
city: North Little Rock
country: United States
state: Arkansas
city: Blue Springs
country: United States
state: Missouri
city: Lake Ozark
country: United States
state: Missouri
city: Warren
country: United States
state: Ohio
city: Kittanning
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Chamberlain
country: United States
state: South Dakota
city: Burlington
country: United States
state: Vermont
Study officials:
References: