Proclear 1-D Multifocal Nondispensing Study

NCT01526902 | Completed Results

• 1 other identifier: CV-12-02A
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Keywords

contact lenses

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Subjective Overall Vision: High Contrast Distance Visual Quality

  After 1 hour of lens wear

• Subjective Vision Assessments: High Contrast Intermediate Visual Quality

  After 1 hour of lens wear

• Subjective Vision Assessments: High Contrast Near Visual Quality

  After 1 hour of lens wear

Study Arms (2)

omafilcon A / PC 1-D MF

ACTIVE COMPARATOR

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; Device: lotrafilcon B / Air Optix MF

lotrafilcon B / Air Optix MF

ACTIVE COMPARATOR

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; Device: lotrafilcon B / Air Optix MF

Interventions

omafilcon A / PC 1-D MF DEVICE

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.

Also known as: Proclear Multifocal daily wear soft contact lenses

lotrafilcon B / Air Optix MF; omafilcon A / PC 1-D MF

lotrafilcon B / Air Optix MF DEVICE

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

Also known as: Air OPtix Aqua Multifocal extended wear soft contact lenses

lotrafilcon B / Air Optix MF; omafilcon A / PC 1-D MF

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Optics Research Lab, Indiana University,

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Pete Kollbaum, OD, PhD, FAAO, FBCLA, Principal Investigator
• Organization: Indiana University

kollbaum@indiana.edu

812-856-0108

Study Officials

• Peter Kollbaum, OD, PhD

  Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 6, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 7, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-03

Locations

US (1)