Trial Outcomes & Findings for Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses (NCT NCT04205162)
NCT ID: NCT04205162
Last Updated: 2023-02-06
Results Overview
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline
Results posted on
2023-02-06
Participant Flow
Participants were recruited at a single site between December 2019 and May 2022. The first participant was enrolled on December 13, 2019 and the last participant was enrolled on May 20, 2022.
Of 40 enrolled participants, 36 met inclusion criteria and were randomized to treatment.
Unit of analysis: eyes
Participant milestones
| Measure |
Verofilcon A / Etafilcon A
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Etafilcon A / Verofilcon A
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
|---|---|---|
|
Overall Study
STARTED
|
18 36
|
18 36
|
|
Overall Study
COMPLETED
|
14 28
|
18 36
|
|
Overall Study
NOT COMPLETED
|
4 8
|
0 0
|
Reasons for withdrawal
| Measure |
Verofilcon A / Etafilcon A
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Etafilcon A / Verofilcon A
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
University closure due to COVID-19
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Verofilcon A / Etafilcon A
n=18 Participants
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Etafilcon A / Verofilcon A
n=18 Participants
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
22.3 Years
STANDARD_DEVIATION 3.3 • n=18 Participants
|
23.7 Years
STANDARD_DEVIATION 4.0 • n=18 Participants
|
23.0 Years
STANDARD_DEVIATION 3.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
22 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
14 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: BaselineAt the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
Outcome measures
| Measure |
Verofilcon A / Etafilcon A
n=18 Participants
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Etafilcon A / Verofilcon A
n=18 Participants
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
|---|---|---|
|
Subjective Ratings of Lens Handling for Insertion Per Intervention
verofilcon A
|
85 score on a scale
Interval 50.0 to 99.0
|
80 score on a scale
Interval 17.0 to 95.0
|
|
Subjective Ratings of Lens Handling for Insertion Per Intervention
etafilcon A
|
75 score on a scale
Interval 10.0 to 100.0
|
85 score on a scale
Interval 50.0 to 99.0
|
PRIMARY outcome
Timeframe: BaselineAt the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.
Outcome measures
| Measure |
Verofilcon A / Etafilcon A
n=18 Participants
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
Etafilcon A / Verofilcon A
n=18 Participants
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
|---|---|---|
|
Subjective Ratings of Lens Handling for Removal Per Intervention
etaflicon A
|
80 score on a scale
Interval 30.0 to 100.0
|
90 score on a scale
Interval 25.0 to 99.0
|
|
Subjective Ratings of Lens Handling for Removal Per Intervention
verofilcon A
|
70 score on a scale
Interval 20.0 to 95.0
|
72.50 score on a scale
Interval 25.0 to 95.0
|
Adverse Events
Ocular Adverse Events Only: Verofilcon A (Per Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ocular Adverse Events Only: Etafilcon A (Per Intervention)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Systemic Adverse Events: Verofilcon A and Etafilcon A
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 |
Ocular Adverse Events Only: Verofilcon A (Per Intervention)
n=36 participants at risk
The participant will wear Verofilcon A in one eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Ocular adverse events are reported per intervention.
|
Ocular Adverse Events Only: Etafilcon A (Per Intervention)
n=36 participants at risk
The participant will wear Etafilcon A in the other eye.
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Ocular adverse events are reported per intervention.
|
Systemic Adverse Events: Verofilcon A and Etafilcon A
n=36 participants at risk
The participant will wear Verofilcon A in one eye and Etafilcon A in the other eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
|
|---|---|---|---|
|
Eye disorders
Ocular irritation
|
0.00%
0/36 • Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
|
2.8%
1/36 • Number of events 1 • Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
|
0.00%
0/36 • Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
|
|
Infections and infestations
COVID-19
|
0.00%
0/36 • Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
|
0.00%
0/36 • Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
|
2.8%
1/36 • Number of events 1 • Average of 1 week
An adverse event was 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place