Refractive Errors
Conditions
Keywords
Myopia
Brief summary
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
Detailed description
In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
Interventions
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection
DEVICECLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution
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: * 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. * Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye. * Willing to stop wearing habitual contact lenses for the duration of study participation. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any eye infection, inflammation, abnormality 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. * Habitual wear of AOHP contact lenses. * Habitual wear of any daily disposable contact lenses. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity With Study Lenses at Week 1 Follow-Up | Week 1, each wear period. A wear period was approximately 14 days. | Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 5 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled participants/eyes (68/136).
Participants by arm
| Arm | Count |
|---|---|
| LID022821, Then AOHP Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. | 34 |
| AOHP, Then LID022821 Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | LID022821, Then AOHP | Total | AOHP, Then LID022821 |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 7.1 | 32.3 years STANDARD_DEVIATION 6.9 | 30.9 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 65 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 68 Participants | 34 Participants |
| Region of Enrollment United States | 34 participants | 68 participants | 34 participants |
| Sex: Female, Male Female | 25 Participants | 52 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 136 | 0 / 68 | 0 / 136 | 0 / 68 |
| other Total, other adverse events | 0 / 68 | 0 / 136 | 0 / 68 | 0 / 136 | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 136 | 0 / 68 | 0 / 136 | 0 / 68 |
Outcome results
Primary
Visual Acuity With Study Lenses at Week 1 Follow-Up
Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.
Time frame: Week 1, each wear period. A wear period was approximately 14 days.
Population: Safety Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID022821 | Visual Acuity With Study Lenses at Week 1 Follow-Up | -0.12 logMAR | Standard Deviation 0.07 |
| AOHP | Visual Acuity With Study Lenses at Week 1 Follow-Up | -0.11 logMAR | Standard Deviation 0.08 |