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OpenTrials
Completed

NCT Number: NCT04205162

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

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Verafilcon A

Device

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

Other names: Precision1™

etafilcon A

Device

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

Other names: Acuvue® Moist

Primary outcomes

  1. Subjective Ratings of Lens Handling for Insertion Per Intervention

    Time frame: Baseline

    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.

  2. Subjective Ratings of Lens Handling for Removal Per Intervention

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Acronym: SALUKI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2019
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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