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

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Verafilcon A; Device: Etafilcon A

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is between 18 and 40 years of age inclusively and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is a neophyte who has no history of any previous contact lens handling experience;
5. Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);
6. Has visual acuity ≤0.20 logMAR each eye with study lenses;
7. Demonstrates acceptable fit with study lenses;
8. 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);
9. Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the study

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has taken part in another clinical research study within the last 14 days;

10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verofilcon A / Etafilcon A; The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.	Device: Verafilcon A; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Precision1™; Device: Etafilcon A; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Acuvue® Moist
EXPERIMENTAL: Etafilcon A / Verofilcon A; The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.	Device: Verafilcon A; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Precision1™; Device: Etafilcon A; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Acuvue® Moist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2019
• Primary Completion (ACTUAL): June 2, 2022
• Study Completion (ACTUAL): June 2, 2022

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (ACTUAL): December 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 41693

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 drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes