Clinical trial NCT04205162: Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses
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
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2019-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Subjective Ratings of Lens Handling for Insertion Per Intervention
timeFrame: Baseline
measure: Subjective Ratings of Lens Handling for Removal Per Intervention
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
affiliation: Centre for Ocular Research & Education
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: