A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: comfilcon A Extended Range test lens; Device: comfilcon A control lens

Detailed Description

This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • CORL, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Has had a self-reported oculo-visual examination in the last two years
• Is 50 years of age or greater and has full legal capacity to volunteer
• Is able to read and understand the informed consent
• Is willing and able to follow instructions and maintain the appointment schedule
• Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
• Near Add Power requirement of +2.25D or greater
• Has spectacle cylinder 0.75 D in both eyes
• Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
• Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
• Has clear corneas and no active ocular disease
• Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has never worn contact lenses before
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications that will affect ocular health
• Has any ocular pathology or abnormality that would affect the wearing of contact lenses
• Is aphakic (i.e. missing their natural lens inside their eye)
• Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: comfilcon A Extended Range test lens; Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.	Device: comfilcon A Extended Range test lens; contact lens; Device: comfilcon A control lens; contact lens
Active Comparator: comfilcon A control lens; Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.	Device: comfilcon A Extended Range test lens; contact lens; Device: comfilcon A control lens; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.	4 days
Visual Performance	Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Preference for Comfort	Subjective preference for comfort for test and control contact lenses.	4 days
Subjective Preference for Intermediate Vision	Subjective preference for intermediate vision for test and control contact lenses.	4 days
Subjective Preference for Distance Vision	Subjective preference for distance vision for test and control contact lenses.	4 days
Average Daily Wearing Time	Average daily wearing time for test and control lens is assessed in hours.	4 days
Subjective Ratings for Comfort	Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	Baseline
Subjective Ratings for Comfort	Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).	4 days
Subjective Ratings for Dryness	Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).	Baseline
Subjective Ratings for Dryness	Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).	4 days
Lens Handling	Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).	4 Days
Lens Fit	Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.	4 days
Bulbar Hyperemia	Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	4 days
Limbal Hyperemia	Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.	4 days
Subjective Satisfaction	Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)	4 days
Subjective Preference for Near Vision	Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.	4 days
Subjective Preference for Overall Vision	Subjective preference for overall vision for test and control contact lenses.	4 days
Subjective Overall Lens Preference	Subjective overall lens preference for test and control contact lenses.	4 days

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Pete S Kollbaum, O.D., Indiana University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CV-16-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes