Proclear 1-D Multifocal Nondispensing Study

Not Applicable

Completed

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

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 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
omafilcon A / PC 1-D MF	lotrafilcon B / Air Optix MF	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.
omafilcon A / PC 1-D MF	omafilcon A / PC 1-D MF	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.
lotrafilcon B / Air Optix MF	omafilcon A / PC 1-D MF	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.
lotrafilcon B / Air Optix MF	lotrafilcon B / Air Optix MF	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.

Primary Outcome Measures

Name	Time	Method
Objective Vision Assessments: High Contrast Distance Visual Acuity	After 1 hour of lens wear	Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Near Visual Acuity	After 1 hour of lens wear	Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Intermediate Visual Acuity	After 1 hour of lens wear	Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.

Secondary Outcome Measures

Name	Time	Method
Subjective Overall Vision: High Contrast Distance Visual Quality	After 1 hour of lens wear	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Subjective Vision Assessments: High Contrast Intermediate Visual Quality	After 1 hour of lens wear	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Subjective Vision Assessments: High Contrast Near Visual Quality	After 1 hour of lens wear	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.