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

NCT04205162 | Completed Results FDA Device

• 1 other identifier: 41693
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Verofilcon A / Etafilcon A

EXPERIMENTAL

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

Device: Verafilcon A; Device: Etafilcon A

Etafilcon A / Verofilcon A

EXPERIMENTAL

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

Device: Verafilcon A; Device: Etafilcon A

Interventions

Verafilcon A DEVICE

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

Also known as: Precision1™

Etafilcon A / Verofilcon A; Verofilcon A / Etafilcon A

Etafilcon A DEVICE

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

Also known as: Acuvue® Moist

Etafilcon A / Verofilcon A; Verofilcon A / Etafilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.

Results Point of Contact

• Title: Jill Woods
• Organization: Centre for Ocular Research and Education

jwoods@uwaterloo.ca

5198884567

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 19, 2019
• Study Start: December 13, 2019
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: February 6, 2023
• Results First Posted: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)