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Proclear 1-D Multifocal Nondispensing Study

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omafilcon A / PC 1-D MF
lotrafilcon B / Air Optix MF
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring contact lenses

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Optics Research Lab, Indiana University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

omafilcon A / PC 1-D MF

lotrafilcon B / Air Optix MF

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 2, 2012
Last Updated
March 7, 2014
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01526902
Brief Title
Proclear 1-D Multifocal Nondispensing Study
Official Title
Proclear 1-D Multifocal Nondispensing Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
contact lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omafilcon A / PC 1-D MF
Arm Type
Active Comparator
Arm 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.
Arm Title
lotrafilcon B / Air Optix MF
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
omafilcon A / PC 1-D MF
Other Intervention Name(s)
Proclear Multifocal daily wear soft contact lenses
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B / Air Optix MF
Other Intervention Name(s)
Air OPtix Aqua Multifocal extended wear soft contact lenses
Intervention Description
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 Measure Information:
Title
Objective Vision Assessments: High Contrast Distance Visual Acuity
Description
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.
Time Frame
After 1 hour of lens wear
Title
Objective Vision Assessments: High Contrast Intermediate Visual Acuity
Description
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.
Time Frame
After 1 hour of lens wear
Title
Objective Vision Assessments: High Contrast Near Visual Acuity
Description
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.
Time Frame
After 1 hour of lens wear
Secondary Outcome Measure Information:
Title
Subjective Overall Vision: High Contrast Distance Visual Quality
Description
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.
Time Frame
After 1 hour of lens wear
Title
Subjective Vision Assessments: High Contrast Intermediate Visual Quality
Description
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.
Time Frame
After 1 hour of lens wear
Title
Subjective Vision Assessments: High Contrast Near Visual Quality
Description
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.
Time Frame
After 1 hour of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kollbaum, OD, PhD
Organizational Affiliation
Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optics Research Lab, Indiana University,
City
Bloomington,
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

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Proclear 1-D Multifocal Nondispensing Study

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