Myopia, Refractive Errors
Conditions
Brief summary
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
Detailed description
The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.
Interventions
DEVICELID220365 contact lens
Investigational delefilcon A spherical contact lens made with a modified manufacturing process
DEVICELID006961 contact lens
Commercially available delefilcon A spherical contact lens
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
Key Inclusion Criteria: * Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * Manifest cylinder equal to or less than 0.75 diopter (D) in each eye. * Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation. * 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. * Habitual monovision or multifocal contact lens wearers. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 | Day 4 | VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 7 investigative sites located in the United States.
Pre-assignment details
Of the 114 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all randomized participants (113).
Participants by arm
| Arm | Count |
|---|---|
| LID220365 (OD) / LID006961 (OS) LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. | 56 |
| LID006961 (OD) / LID220365 (OS) LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day. | 57 |
| Total | 113 |
Baseline characteristics
| Characteristic | LID006961 (OD) / LID220365 (OS) | LID220365 (OD) / LID006961 (OS) | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 7.9 | 33.2 years STANDARD_DEVIATION 8.2 | 33.5 years STANDARD_DEVIATION 8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 Participants | 5 Participants | 14 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 48 Participants | 51 Participants | 99 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 46 Participants | 47 Participants | 93 Participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 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 / 113 | 0 / 113 | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 0 / 113 | 0 / 113 | 0 / 113 | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 | 0 / 113 | 0 / 113 |
Outcome results
Primary
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Day 4
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LID220365 | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 | -0.13 logMAR | Standard Error 0.006 |
| LID006961 | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 | -0.13 logMAR | Standard Error 0.006 |