Myopia, Refractive Errors
Conditions
Keywords
soft contact lenses, vision, eyesight
Brief summary
The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
Detailed description
Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
Interventions
Daily disposable soft contact lenses
Daily disposable soft contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * Best corrected VA 20/25 or better in each eye. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any current or prior wear experience with DT1 lenses. * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense, Week 1, Week 2, Month 1, Month 2, Month 3 | VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 6 investigational sites located in the US.
Pre-assignment details
This reporting group includes all randomized subjects (107).
Participants by arm
| Arm | Count |
|---|---|
| DD T2 Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day. | 70 |
| DT 1 Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. | 37 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision - prior to dispense | 0 | 1 |
| Overall Study | Subject moved | 1 | 0 |
Baseline characteristics
| Characteristic | DD T2 | DT 1 | Total |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 6.3 | 31.3 years STANDARD_DEVIATION 7.6 | 33.3 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Multi-racial | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 65 participants | 33 participants | 98 participants |
| Sex: Female, Male Female | 51 Participants | 30 Participants | 81 Participants |
| Sex: Female, Male Male | 19 Participants | 7 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 0 / 69 | 0 / 72 | 0 / 36 |
| other Total, other adverse events | 0 / 138 | 0 / 69 | 0 / 72 | 0 / 36 |
| serious Total, serious adverse events | 0 / 138 | 0 / 69 | 0 / 72 | 0 / 36 |
Outcome results
Primary
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Time frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
Population: Completed Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/20 | 58 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/30 | 1 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/15 | 74 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/20 | 62 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/25 | 2 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/30 | 0 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/15 | 75 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/25 | 4 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/15 | 69 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/20 | 65 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/25 | 4 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/30 | 0 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/15 | 62 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/20 | 72 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/25 | 4 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/30 | 0 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/15 | 63 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/20 | 68 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/25 | 7 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/30 | 0 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/15 | 63 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/20 | 69 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/25 | 6 eyes |
| DD T2 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/25 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/15 | 31 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/25 | 3 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/15 | 32 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/20 | 40 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/20 | 40 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/20 | 37 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/25 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/25 | 1 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Dispense @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/15 | 36 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/25 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/20 | 36 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 1 @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 1 @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/30 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/15 | 35 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/15 | 33 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/20 | 37 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 3 @ 20/15 | 35 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/25 | 0 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Month 2 @ 20/20 | 36 eyes |
| DT 1 | Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | Week 2 @ 20/30 | 0 eyes |