Trial Outcomes & Findings for Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users (NCT NCT04201639)

NCT ID: NCT04201639

Last Updated: 2023-01-26

Results Overview

Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Dispense Visit (Day 0)
• Results posted on: 2023-01-26

Participant Flow

Participant milestones

Measure	Refit Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Age, Continuous	25.8 years STANDARD_DEVIATION 6.0 • n=32 Participants
Sex: Female, Male Female	27 Participants n=32 Participants
Sex: Female, Male Male	5 Participants n=32 Participants
Region of Enrollment Canada	32 participants n=32 Participants

PRIMARY outcome

Timeframe: Dispense Visit (Day 0)

Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort After Contact Lens Insertion	95 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Dispense Visit (Day 0)

Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness After Contact Lens Insertion	100 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Dispense Visit (Day 0)

Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	98 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort After Contact Lens Insertion	96 score on a scale Interval 75.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness After Contact Lens Insertion	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	99 score on a scale Interval 78.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort After Contact Lens Insertion	98 score on a scale Interval 75.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness After Contact Lens Insertion	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort After Contact Lens Insertion	95 score on a scale Interval 65.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness After Contact Lens Insertion	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	95 score on a scale Interval 75.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort After Contact Lens Insertion	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness After Contact Lens Insertion	90 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	91 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	99 score on a scale Interval 85.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	100 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	95 score on a scale Interval 65.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 75.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 67.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	95 score on a scale Interval 65.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 55.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	90 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort at End of Day With Contact Lens Wear	100 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness at End of Day With Contact Lens Wear	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 1

Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	100 score on a scale Interval 80.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort at End of Day With Contact Lens Wear	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness at End of Day With Contact Lens Wear	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 7

Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	95 score on a scale Interval 65.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort at End of Day With Contact Lens Wear	89 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness at End of Day With Contact Lens Wear	85 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 10

Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90 score on a scale Interval 62.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Comfort at End of Day With Contact Lens Wear	90 score on a scale Interval 60.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Dryness at End of Day With Contact Lens Wear	88 score on a scale Interval 45.0 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Refit n=32 Participants Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90 score on a scale Interval 70.0 to 100.0

Adverse Events

Refit

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Refit n=32 participants at risk Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Eye disorders Small fibre embdeed in superficial epithelium of left cornea	3.1% 1/32 • Number of events 1 • 12-16 days Regular investigator assessment. Adverse events were defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.

Additional Information

Jill Woods

Centre for Ocular Research and Education

Phone: 5198884567

Email: jwoods@uwaterloo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place