Proclear 1-D Multifocal Nondispensing Study

Completed · Not applicable

Conditions studied: Presbyopia

In brief

This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

Key facts

Study ID

NCT01526902

Run by

CooperVision, Inc.

People needed

49

Starts

2012-02-01

Expected to finish

2012-05-01

Last updated by the study team

2014-04-07

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Optics Research Lab, Indiana University, — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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