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Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses (SALUKI)

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Verafilcon A

Etafilcon A

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Is between 18 and 40 years of age inclusively and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a neophyte who has no history of any previous contact lens handling experience;
Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);
Has visual acuity ≤0.20 logMAR each eye with study lenses;
Demonstrates acceptable fit with study lenses;
Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye);
Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the study

Exclusion Criteria:

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
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 a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
Is aphakic;
Has undergone refractive error surgery;
Has taken part in another clinical research study within the last 14 days;
Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
- For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sites / Locations

Centre for Ocular Research & Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Verofilcon A / Etafilcon A

Etafilcon A / Verofilcon A

Arm Description

The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.

The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.

Outcomes

Primary Outcome Measures

Subjective Ratings of Lens Handling for Insertion Per Intervention

At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.

Subjective Ratings of Lens Handling for Removal Per Intervention

At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.

Secondary Outcome Measures

Full Information

NCT ID

NCT04205162

First Posted

December 13, 2019

Last Updated

January 9, 2023

Sponsor

University of Waterloo

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT04205162

Brief Title

Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

Acronym

SALUKI

Official Title

Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 13, 2019 (Actual)

Primary Completion Date

June 2, 2022 (Actual)

Study Completion Date

June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Waterloo

Collaborators

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist).

6. Conditions and Keywords

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

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Participants and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verofilcon A / Etafilcon A

Arm Type

Experimental

Arm Description

The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.

Arm Title

Etafilcon A / Verofilcon A

Arm Type

Experimental

Arm Description

The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.

Intervention Type

Device

Intervention Name(s)

Verafilcon A

Other Intervention Name(s)

Precision1™

Intervention Description

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Intervention Type

Device

Intervention Name(s)

Etafilcon A

Other Intervention Name(s)

Acuvue® Moist

Intervention Description

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Primary Outcome Measure Information:

Title

Subjective Ratings of Lens Handling for Insertion Per Intervention

Description

Time Frame

Baseline

Title

Subjective Ratings of Lens Handling for Removal Per Intervention

Description

At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is between 18 and 40 years of age inclusively and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is a neophyte who has no history of any previous contact lens handling experience; Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane); Has visual acuity ≤0.20 logMAR each eye with study lenses; Demonstrates acceptable fit with study lenses; Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye); Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the study Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; 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 a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report); Is aphakic; Has undergone refractive error surgery; Has taken part in another clinical research study within the last 14 days; Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables. For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lyndon Jones, PhD, FCOptom

Organizational Affiliation

Centre for Ocular Research & Education

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Ocular Research & Education

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2L 3G1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

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