Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

Myopia Clinical Trial

— PUG  

Official title:

Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201639
• Other study ID #: 41694
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2023
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Verofilcon A contact lenses
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Locations

Country	Name	City	State
Canada	Centre for Ocular Research & Education	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Primary	Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Primary	Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Primary	Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Comfort After Contact Lens Insertion	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)
Primary	Subjective Dryness After Contact Lens Insertion	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)
Primary	Subjective Rating of Clarity of Vision After Contact Lens Insertion	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)
Primary	Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	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)
Primary	Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	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)
Primary	Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	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)
Primary	Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).	Day 1
Primary	Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).	Day 7
Primary	Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).	Day 10
Primary	Subjective Comfort at End of Day With Contact Lens Wear	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)
Primary	Subjective Dryness at End of Day With Contact Lens Wear	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)
Primary	Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	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)