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Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Primary Purpose

Myopia, Hyperopia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control Contact Lens
Test Contact Lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Refractive Errors, Eye Diseases

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Are 17 to 40 years of age and have full legal capacity to volunteer; Have read and signed an information consent letter; Are willing and able to follow instructions and maintain the appointment schedule; Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye Are correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction; Have an astigmatism of ≤ 0.75DC in subjective refraction; Can be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit. Demonstrate an acceptable fit with the study lenses. Exclusion Criteria: Have taken part in another clinical research study within the last 14 days; Are currently habitual wearers of toric, multifocal or monovision lenses. Have worn any rigid contact lenses in the past 6 months Are an extended lens wearer (i.e., sleeping with their lenses) Have a difference of ≥1.5 D in best vision sphere subjective refraction between eyes; Have amblyopia and/or distance strabismus/binocular vision problem; Have any known active ocular disease, allergies and/or infection; Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study; Have undergone refractive error surgery or intraocular surgery; Are a member of CORE directly involved in the study.

Sites / Locations

  • University of Waterloo School of Optometry & Vision ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Lens, then Test Lens

Test Lens, then Control Lens

Arm Description

Participants will wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes.

Participants will wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes.

Outcomes

Primary Outcome Measures

Lens Handling at Insertion
Binocular subjective rating of the ease of lens application to eye, using a 0-100 scale (0=Very difficult, 100=Very easy)

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
October 3, 2023
Sponsor
Coopervision, Inc.
Collaborators
CORE
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1. Study Identification

Unique Protocol Identification Number
NCT06046209
Brief Title
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
Official Title
Comparing Clariti Elite Versus Proclear 1 Day
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Detailed Description
This is a non-dispensing, randomized, double-masked, crossover study. Participants will wear 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant is 4 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
Keywords
Refractive Errors, Eye Diseases

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control Lens, then Test Lens
Arm Type
Experimental
Arm Description
Participants will wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes.
Arm Title
Test Lens, then Control Lens
Arm Type
Experimental
Arm Description
Participants will wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes.
Intervention Type
Device
Intervention Name(s)
Control Contact Lens
Intervention Description
Daily disposable contact lens for 90 minutes
Intervention Type
Device
Intervention Name(s)
Test Contact Lens
Intervention Description
Monthly replacement contact lens for 90 minutes
Primary Outcome Measure Information:
Title
Lens Handling at Insertion
Description
Binocular subjective rating of the ease of lens application to eye, using a 0-100 scale (0=Very difficult, 100=Very easy)
Time Frame
90 minutes of wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are 17 to 40 years of age and have full legal capacity to volunteer; Have read and signed an information consent letter; Are willing and able to follow instructions and maintain the appointment schedule; Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye Are correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction; Have an astigmatism of ≤ 0.75DC in subjective refraction; Can be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit. Demonstrate an acceptable fit with the study lenses. Exclusion Criteria: Have taken part in another clinical research study within the last 14 days; Are currently habitual wearers of toric, multifocal or monovision lenses. Have worn any rigid contact lenses in the past 6 months Are an extended lens wearer (i.e., sleeping with their lenses) Have a difference of ≥1.5 D in best vision sphere subjective refraction between eyes; Have amblyopia and/or distance strabismus/binocular vision problem; Have any known active ocular disease, allergies and/or infection; Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study; Have undergone refractive error surgery or intraocular surgery; Are a member of CORE directly involved in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Hall, PhD MCOptom
Phone
+19252516684
Email
LHall@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
Centre for Ocular Research and Education (CORE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo School of Optometry & Vision Science
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

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