Clinical trial NCT04201639: Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
Official title: Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2019-12-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).


Eligibility criteria: Inclusion Criteria:

1. Is between 18 and 40 years of age (inclusive) 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 heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
9. Is willing to wear Precision1 CLs at least 5 days per week and 10 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;
7. Is aphakic;
8. Has undergone refractive error surgery;

   * 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 Comfort After Contact Lens Insertion
timeFrame: Dispense Visit (Day 0)
measure: Subjective Dryness After Contact Lens Insertion
timeFrame: Dispense Visit (Day 0)
measure: Subjective Rating of Clarity of Vision After Contact Lens Insertion
timeFrame: Dispense Visit (Day 0)
measure: Subjective Comfort After Contact Lens Insertion
timeFrame: Day 1
measure: Subjective Dryness After Contact Lens Insertion
timeFrame: Day 1
measure: Subjective Rating of Clarity of Vision After Contact Lens Insertion
timeFrame: Day 1
measure: Subjective Comfort After Contact Lens Insertion
timeFrame: Day 7
measure: Subjective Dryness After Contact Lens Insertion
timeFrame: Day 7
measure: Subjective Rating of Clarity of Vision After Contact Lens Insertion
timeFrame: Day 7
measure: Subjective Comfort After Contact Lens Insertion
timeFrame: Day 10
measure: Subjective Dryness After Contact Lens Insertion
timeFrame: Day 10
measure: Subjective Rating of Clarity of Vision After Contact Lens Insertion
timeFrame: Day 10
measure: Subjective Comfort After Contact Lens Insertion
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Dryness After Contact Lens Insertion
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Rating of Clarity of Vision After Contact Lens Insertion
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 1
measure: Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 1
measure: Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 1
measure: Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 7
measure: Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 7
measure: Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 7
measure: Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 10
measure: Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 10
measure: Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Day 10
measure: Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 1
measure: Subjective Dryness at End of Day With Contact Lens Wear
timeFrame: Day 1
measure: Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
timeFrame: Day 1
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 7
measure: Subjective Dryness at End of Day With Contact Lens Wear
timeFrame: Day 7
measure: Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
timeFrame: Day 7
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 10
measure: Subjective Dryness at End of Day With Contact Lens Wear
timeFrame: Day 10
measure: Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
timeFrame: Day 10
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Dryness at End of Day With Contact Lens Wear
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
measure: Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
timeFrame: Followup visit (occurring at a single visit any day from Day 12-16)
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: