Astigmatism
Conditions
Keywords
Astigmatism, Axis orientation
Brief summary
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
Interventions
DEVICELotrafilcon B toric contact lenses with HYDRAGLYDE
Silicone hydrogel soft contact lenses for astigmatism
DEVICELotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day * Astigmatism * Requires contact lenses * Best corrected visual acuity of 20/25 or better in each eye * Other protocol-specified inclusion criteria may apply
Exclusion criteria
* Any eye condition that contraindicates contact lens wear, as determined by the Investigator * Any eye surgery that contraindicates contact lens wear, as determined by the Investigator * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | Day 1, 10 minutes after lens insertion, each product | Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one investigative site located in the US.
Pre-assignment details
This reporting group includes all enrolled subjects (36).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 13.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 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 | 27 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
Time frame: Day 1, 10 minutes after lens insertion, each product
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AOHG Toric | Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | 94.4 percentage of lenses |
| AO Toric | Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | 95.8 percentage of lenses |