Proclear 1-D Multifocal Nondispensing Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526902

Enrollment

Registered

2012-02-06

Start date

2012-02-29

Completion date

2012-05-31

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

contact lenses

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).

Interventions

DEVICEomafilcon 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.

DEVICElotrafilcon B / Air Optix MF

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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 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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Recruitment details

Recruitment was open between 06FEB2012 and 28FEB2012

Pre-assignment details

The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.

Participants by arm

Arm	Count
Overall Study Population 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.	49
Total	49

Baseline characteristics

Characteristic	Overall Study Population
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	49 Participants
Age, Continuous	53 years STANDARD_DEVIATION 6
Region of Enrollment United States	49 participants
Sex: Female, Male Female	39 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 49	0 / 49
serious Total, serious adverse events	0 / 49	0 / 49

Outcome results

Primary

Objective Vision Assessments: High Contrast Distance Visual Acuity

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.