Refractive Errors
Conditions
Keywords
Vision, Contact lenses
Brief summary
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
Detailed description
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.
Interventions
DEVICELID021201 contact lenses
Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear
DEVICEOPTI-FREE multipurpose solution
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Lens will be provided with investigational product labeling
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Understand and sign an Informed Consent that has been approved by an Institutional Review Board. * Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * Willing to stop wearing habitual contact lenses for the duration of study participation. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any condition that contraindicates contact lens wear, as determined by the Investigator. * Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator. * History of refractive surgery or plan to have refractive surgery during the study. * Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear. * Wears 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-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Front Surface Wettability, by Category | Dispense; Week 1 Follow-up | Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at 3 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization (Safety Analysis Set).
Participants by arm
| Arm | Count |
|---|---|
| LID021201 LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event Unrelated to the Study Device | 1 |
Baseline characteristics
| Characteristic | LID021201 |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 78 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 78 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 78 | 0 / 39 |
Outcome results
Primary
Front Surface Wettability, by Category
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Time frame: Dispense; Week 1 Follow-up
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LID021201 | Front Surface Wettability, by Category | Week 1 Follow-up, Grade 1 | 19 eyes |
| LID021201 | Front Surface Wettability, by Category | Dispense, Grade 0 | 78 eyes |
| LID021201 | Front Surface Wettability, by Category | Dispense, Grade 1 | 0 eyes |
| LID021201 | Front Surface Wettability, by Category | Dispense, Grade 2 | 0 eyes |
| LID021201 | Front Surface Wettability, by Category | Dispense, Grade 3 | 0 eyes |
| LID021201 | Front Surface Wettability, by Category | Dispense, Grade 4 | 0 eyes |
| LID021201 | Front Surface Wettability, by Category | Week 1 Follow-up, Grade 0 | 56 eyes |
| LID021201 | Front Surface Wettability, by Category | Week 1 Follow-up, Grade 2 | 1 eyes |
| LID021201 | Front Surface Wettability, by Category | Week 1 Follow-up, Grade 3 | 0 eyes |
| LID021201 | Front Surface Wettability, by Category | Week 1 Follow-up, Grade 4 | 0 eyes |