Refractive Errors
Conditions
Keywords
contact lens, contact lens solution
Brief summary
The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.
Detailed description
Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.
Interventions
DEVICELID018869+RepleniSH
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
DEVICELID018869+Biotrue
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
DEVICEBiofinity+RepleniSH
Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
DEVICEPV+Biotrue
Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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: * Understand and sign an Informed Consent; * Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye; * Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye; * Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; * Eye surgery, as specified in the protocol; * Dry eye; use of artificial tears, as specified in the protocol; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Percent Area of Corneal Staining | Hour 2 (each wear period) | A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one investigative site located in the United States.
Pre-assignment details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours. | 9 |
| Sequence 2 Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was 2 hours. | 9 |
| Sequence 3 LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours. | 9 |
| Sequence 4 PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours. | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Sequence 1 | Total | Sequence 4 | Sequence 3 | Sequence 2 |
|---|---|---|---|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 5.4 | 31.8 years STANDARD_DEVIATION 6.4 | 31.6 years STANDARD_DEVIATION 6.3 | 36.0 years STANDARD_DEVIATION 6.8 | 29.0 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 32 Participants | 9 Participants | 7 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 35 Participants | 9 Participants | 8 Participants | 9 Participants |
| Region of Enrollment United States | 9 participants | 36 participants | 9 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 27 Participants | 8 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Average Percent Area of Corneal Staining
A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Time frame: Hour 2 (each wear period)
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID018869+RepleniSH | Average Percent Area of Corneal Staining | 2.93 percentage of area | Standard Deviation 8.86 |
| Biofinity+RepleniSH | Average Percent Area of Corneal Staining | 0.45 percentage of area | Standard Deviation 1.03 |
| LID018869+Biotrue | Average Percent Area of Corneal Staining | 6.06 percentage of area | Standard Deviation 14.75 |
| PV+Biotrue | Average Percent Area of Corneal Staining | 3.52 percentage of area | Standard Deviation 11.87 |