Refractive Errors, Ametropia
Conditions
Keywords
Contact Lenses
Brief summary
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Detailed description
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits. Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
Interventions
Investigational soft contact lenses for daily wear worn in Part A of the study
Commercially available soft contact lenses for daily wear worn in Part A of the study
Commercially available soft contact lenses for daily wear worn in Part B of the study
DEVICEHydrogen peroxide-based cleaning and disinfecting solution
For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part A is double masked. Part B is single masked (trial subject).
Intervention model description
Part A is a crossover study. Part B is a single group study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Sign an approved Informed Consent Form. * Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Any eye condition or use of medication 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. * Routinely sleeps in contact lenses at least 1 night per week. * Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS. * Part B: Current wearer of Biofinity family of contact lenses (comfilcon A). * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) (Part A) | Day 30, each study lens type | Distance VA was assessed with study lenses in place. VA was collected for each eye separately 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4 investigative sites located in the United States.
Participants by arm
| Arm | Count |
|---|---|
| LID018869, Then AOHP (Part A) Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | 33 |
| AOHP, Then LID018869 (Part A) Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | 33 |
| Biofinity (Part B) Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | 66 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Wear Period (30 Days) | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | LID018869, Then AOHP (Part A) | AOHP, Then LID018869 (Part A) | Biofinity (Part B) | Total |
|---|---|---|---|---|
| Age, Customized 18-64 years | 33 Participants | 33 Participants | 66 Participants | 132 Participants |
| Age, Customized Equal to or greater than 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 61 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 32 Participants | 62 Participants | 125 Participants |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 49 Participants | 95 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 17 Participants | 37 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 | 0 / 66 | 0 / 132 | 0 / 66 |
| other Total, other adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 | 0 / 66 | 0 / 132 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 | 0 / 66 | 0 / 132 | 0 / 66 |
Outcome results
Primary
Distance Visual Acuity (VA) (Part A)
Distance VA was assessed with study lenses in place. VA was collected for each eye separately 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Time frame: Day 30, each study lens type
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID018869 (Part A) | Distance Visual Acuity (VA) (Part A) | -0.12 logMAR | Standard Deviation 0.09 |
| AOHP (Part A) | Distance Visual Acuity (VA) (Part A) | -0.12 logMAR | Standard Deviation 0.09 |