Proclear 1-D Multifocal Nondispensing Study - Full Text View

Purpose

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

Condition	Intervention
Presbyopia	Device: omafilcon A / PC 1-D MF Device: lotrafilcon B / Air Optix MF


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Proclear 1-D Multifocal Nondispensing Study

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:

Objective Vision Assessments: High Contrast Distance Visual Acuity [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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 [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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 [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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 Outcome Measures:

Subjective Overall Vision: High Contrast Distance Visual Quality [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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 [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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 [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
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.


Enrollment:	49
Study Start Date:	February 2012
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Air OPtix Aqua Multifocal extended wear soft contact lenses

Arms

Assigned Interventions

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 Name: 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 Name: 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 Name: 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 Name: Air OPtix Aqua Multifocal extended wear 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).

Eligibility


Ages Eligible for Study:	40 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526902

Locations


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

Sponsors and Collaborators

Coopervision, Inc.

Investigators


Principal Investigator:	Peter Kollbaum, OD, PhD	Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

More Information


Responsible Party:	Coopervision, Inc.
ClinicalTrials.gov Identifier:	NCT01526902 History of Changes
Other Study ID Numbers:	CV-12-02A
Study First Received:	February 2, 2012
Results First Received:	November 1, 2013
Last Updated:	March 7, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:


contact lenses

Additional relevant MeSH terms:


Presbyopia Refractive Errors Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2016