Status:
COMPLETED
Proclear 1-D Multifocal Nondispensing Study
Lead Sponsor:
CooperVision, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.
Detailed Description
The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01526902
Start Date
February 1 2012
End Date
May 1 2012
Last Update
April 7 2014
Active Locations (1)
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1
Clinical Optics Research Lab, Indiana University,
Bloomington, Indiana, United States, 47405