Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users (PUG)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3G1
- Centre for Ocular Research & Education
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Is between 18 and 40 years of age (inclusive) 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 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);
- 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;
- Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
- Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
- Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
- Is willing to wear Precision1 CLs at least 5 days per week and 10 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;
- Is aphakic;
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Refit
Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.
|
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Comfort After Contact Lens Insertion
Time Frame: Dispense Visit (Day 0)
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Dispense Visit (Day 0)
|
|
Subjective Dryness After Contact Lens Insertion
Time Frame: Dispense Visit (Day 0)
|
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
|
Dispense Visit (Day 0)
|
|
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time Frame: Dispense Visit (Day 0)
|
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
|
Dispense Visit (Day 0)
|
|
Subjective Comfort After Contact Lens Insertion
Time Frame: Day 1
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Dryness After Contact Lens Insertion
Time Frame: Day 1
|
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time Frame: Day 1
|
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Comfort After Contact Lens Insertion
Time Frame: Day 7
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Dryness After Contact Lens Insertion
Time Frame: Day 7
|
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time Frame: Day 7
|
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Comfort After Contact Lens Insertion
Time Frame: Day 10
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Dryness After Contact Lens Insertion
Time Frame: Day 10
|
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time Frame: Day 10
|
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Comfort After Contact Lens Insertion
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Dryness After Contact Lens Insertion
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 1
|
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 1
|
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 1
|
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 7
|
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 7
|
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 7
|
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 10
|
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 10
|
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Day 10
|
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Comfort at End of Day With Contact Lens Wear
Time Frame: Day 1
|
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Dryness at End of Day With Contact Lens Wear
Time Frame: Day 1
|
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time Frame: Day 1
|
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
|
Day 1
|
|
Subjective Comfort at End of Day With Contact Lens Wear
Time Frame: Day 7
|
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Dryness at End of Day With Contact Lens Wear
Time Frame: Day 7
|
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time Frame: Day 7
|
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
|
Day 7
|
|
Subjective Comfort at End of Day With Contact Lens Wear
Time Frame: Day 10
|
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Dryness at End of Day With Contact Lens Wear
Time Frame: Day 10
|
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time Frame: Day 10
|
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
|
Day 10
|
|
Subjective Comfort at End of Day With Contact Lens Wear
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Dryness at End of Day With Contact Lens Wear
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
|
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time Frame: Followup visit (occurring at a single visit any day from Day 12-16)
|
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
|
Followup visit (occurring at a single visit any day from Day 12-16)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 41694
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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