Proclear 1-D Multifocal Nondispensing Study

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: lotrafilcon B / Air Optix MF; Device: omafilcon A / PC 1-D MF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526902

CV-12-02A

Details and patient eligibility

About

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

Full 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 compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Enrollment: 49 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 2 patient groups

omafilcon A / PC 1-D MF

Active Comparator group

Description:

omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Treatment:

Device: omafilcon A / PC 1-D MF

Device: lotrafilcon B / Air Optix MF

lotrafilcon B / Air Optix MF

Active Comparator group

Description:

lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Treatment:

Device: omafilcon A / PC 1-D MF

Device: lotrafilcon B / Air Optix MF