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Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Primary Purpose

Astigmatism

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lens A (comfilcon A toric lens)
Lens B (lehfilcon A toric lens)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer; Has read and signed an information consent letter; Self-reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears of toric soft contact lenses binocularly. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses; the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%)) iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%)) iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage) v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage) vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage) vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage) Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC; Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively; Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Sites / Locations

  • Sacco Eye Group
  • ProCare Vision Center
  • Eyes on Sheppard Clinic
  • Spadina Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lens A, Then Lens B

Lens B, Then Lens A

Arm Description

Participants will wear Lens A for one month and then crossover to Lens B for one month.

Participants will wear Lens B for one month and then crossover to Lens A for one month.

Outcomes

Primary Outcome Measures

Lens Handling on Removal
Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best)

Secondary Outcome Measures

Distance Visual Acuity
Distance Visual Acuity, using Snellen converted to logMAR

Full Information

First Posted
June 28, 2023
Last Updated
July 5, 2023
Sponsor
Coopervision, Inc.
Collaborators
CORE
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1. Study Identification

Unique Protocol Identification Number
NCT05933772
Brief Title
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Official Title
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 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 objective of the study is to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
Detailed Description
This study is a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lens A, Then Lens B
Arm Type
Experimental
Arm Description
Participants will wear Lens A for one month and then crossover to Lens B for one month.
Arm Title
Lens B, Then Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens B for one month and then crossover to Lens A for one month.
Intervention Type
Device
Intervention Name(s)
Lens A (comfilcon A toric lens)
Intervention Description
One month wear
Intervention Type
Device
Intervention Name(s)
Lens B (lehfilcon A toric lens)
Intervention Description
One month wear
Primary Outcome Measure Information:
Title
Lens Handling on Removal
Description
Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best)
Time Frame
One month of wear
Secondary Outcome Measure Information:
Title
Distance Visual Acuity
Description
Distance Visual Acuity, using Snellen converted to logMAR
Time Frame
One month wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer; Has read and signed an information consent letter; Self-reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears of toric soft contact lenses binocularly. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses; the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%)) iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%)) iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage) v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage) vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage) vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage) Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC; Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively; Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Vega, OD,MSc,FAAO
Phone
9256213761
Email
jvega2@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sacco
Organizational Affiliation
Sacco Eye Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wilkinson
Organizational Affiliation
Spadina Optometry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona Soong
Organizational Affiliation
Eyes on Sheppard Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Bickle
Organizational Affiliation
ProCare Vision Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Sacco
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Bickle
Facility Name
Eyes on Sheppard Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Soong
Facility Name
Spadina Optometry
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 3E7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wilkinson

12. IPD Sharing Statement

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Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

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