Proclear 1-D Multifocal Nondispensing Study

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: omafilcon A / PC 1-D MF; Device: lotrafilcon B / Air Optix MF

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).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington,, Indiana, United States, 47405
      • Clinical Optics Research Lab, Indiana University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.; Other Names: Proclear Multifocal daily wear soft contact lenses; Device: 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; Other Names: Air OPtix Aqua Multifocal extended wear soft contact lenses
Active Comparator: 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.	Device: 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.; Other Names: Proclear Multifocal daily wear soft contact lenses; Device: 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; Other Names: Air OPtix Aqua Multifocal extended wear soft contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 1 hour of lens wear
Objective Vision Assessments: High Contrast Intermediate Visual Acuity	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.	After 1 hour of lens wear
Objective Vision Assessments: High Contrast Near Visual Acuity	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.	After 1 hour of lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Vision: High Contrast Distance Visual Quality	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.	After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Intermediate Visual Quality	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.	After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Near Visual Quality	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.	After 1 hour of lens wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Peter Kollbaum, OD, PhD, Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: March 7, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CV-12-02A