Multifocal NonDispensing Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Coopervision, Inc.

ClinicalTrials.gov Identifier:

NCT01526902

First received: February 2, 2012

Last updated: April 30, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 2, 2012

Last Updated Date

April 30, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Acuity [ Time Frame: after 1 hour of wear ] [ Designated as safety issue: No ]

Tested with reading 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 and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01526902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multifocal NonDispensing Study

Official Title ^ICMJE

Proclear 1-D Multifocal Nondispensing Study

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Presbyopia

Intervention ^ICMJE

Device: omafilcon A multifocal
Omafilcon A 1-D multifocal daily wear soft contact lens
Device: lotrafilcon B multifocal
Lotrafilcon B multifocal extended wear soft contact lens

Study Arm (s)

Active Comparator: omafilcon A/lotrafilcon B
omafilcon A soft contact lens worn 1st then cross over and subject wears the lotrafilcon B lens 2nd.
Interventions:
- Device: omafilcon A multifocal
- Device: lotrafilcon B multifocal
Active Comparator: lotrafilcon B/ omafilcon A
lotrafilcon B soft contact lens worn 1st then cross over and subject wears the omafilcon A lens 2nd.
Interventions:
- Device: omafilcon A multifocal
- Device: lotrafilcon B multifocal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01526902

Other Study ID Numbers ^ICMJE

CV-12-02A

Has Data Monitoring Committee

Responsible Party

Coopervision, Inc.

Study Sponsor ^ICMJE

Coopervision, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Kollbaum, OD, PhD

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

Information Provided By

Coopervision, Inc.

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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