N/A
N=49
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01016652 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire — 41.0; 39.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A multifocal contact lens (Device); etafilcon A Contact Lens (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire |
41.0; 39.0 | — |
| PRIMARY Monocular Amplitude of Accommodation |
0.00; 0.00 | — |
| SECONDARY Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ |
53; 43 | — |
| SECONDARY Subject Reported Lens Comfort Using CLUE Questionnaire |
59.0; 59.0 | — |
| SECONDARY Comfortable Wearing Time |
14; 14 | — |
| SECONDARY Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper |
52; 58 | — |
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:
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT01016652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.