N/A
N=49
Proclear 1-D Multifocal Nondispensing Study
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01526902 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Objective Vision Assessments: High Contrast Distance Visual Acuity — -0.09; -0.05 logMAR units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- omafilcon A / PC 1-D MF (Device); lotrafilcon B / Air Optix MF (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Vision Assessments: High Contrast Distance Visual Acuity |
-0.09; -0.05 | — |
| PRIMARY Objective Vision Assessments: High Contrast Intermediate Visual Acuity |
-0.11; -0.10 | — |
| PRIMARY Objective Vision Assessments: High Contrast Near Visual Acuity |
0.08; 0.05 | — |
| SECONDARY Subjective Overall Vision: High Contrast Distance Visual Quality |
87; 88 | — |
| SECONDARY Subjective Vision Assessments: High Contrast Intermediate Visual Quality |
85; 85 | — |
| SECONDARY Subjective Vision Assessments: High Contrast Near Visual Quality |
81; 80 | — |
Summary
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.
Eligibility Criteria
Inclusion Criteria
- Be between 40 and 65 years of age (inclusive)
- Require a reading addition of +1.25 to +2.50D (inclusive)
- Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
- Spectacle cylinder less than or equal to 0.75D in both eyes.
- Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
- Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Have a minimum 2 weeks soft contact lens experience
- Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
- No gas permeable contact lens wear for 1 month prior to the study
Exclusion Criteria
To be eligible for the study, each candidate must not present with any of the following
- Any active corneal infection, injury, inflammation, or ocular abnormality
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease, which might interfere with contact lens wear
- Ocular disease, which might interfere with contact lens wear
- Pregnant or lactating
- Strabismus/amblyopia
- Habitually uncorrected anisometropia greater than or equal to 2.00 D
- Subjects who have undergone corneal refractive surgery
- Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Data sourced from ClinicalTrials.gov (NCT01526902). 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.