Refractive Error, Myopia, Myopic Astigmatism
Conditions
Keywords
Soft contact lenses, DACP
Brief summary
The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20 * Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week * Those who play ball sports at least 1 day per week * Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Those who regularly wear the study device * Those who require ocular treatment with eye drops * Those who have a condition contraindicating soft contact lens wear, such as eye irritation * Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study * Those who are participating in another clinical study or research or have a plan of such participation during the present study * Women who are pregnant or intend to become pregnant during the study * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Investigator-Rated Lens Centration | After 1 week of wear | Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Investigator-Rated Lens Fit | After 1 week of wear | Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean. |
| Average Subjective Ratings Score (Lens Handling and Overall Vision) | After 1 week of wear | The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean. |
| Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | After 1 week of wear | The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. Overall Vision was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean. |
Participant flow
Recruitment details
Participants were recruited from 5 study centers located in Japan.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Mean Investigator-Rated Lens Centration
Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.
Time frame: After 1 week of wear
Population: This analysis population includes all enrolled participants minus missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP | Mean Investigator-Rated Lens Centration | 0.34 units on a scale | Standard Deviation 0.47 |
| 1DAM | Mean Investigator-Rated Lens Centration | 0.73 units on a scale | Standard Deviation 0.83 |
Secondary
Average Subjective Ratings Score (Lens Handling and Overall Vision)
The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Time frame: After 1 week of wear
Population: This analysis population includes all enrolled participants minus missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DACP | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Ease of insertion | 7.8 units on a scale | Standard Deviation 2 |
| DACP | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Ease of removal | 7.2 units on a scale | Standard Deviation 2.5 |
| DACP | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Overall vision | 8.1 units on a scale | Standard Deviation 1.9 |
| 1DAM | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Ease of insertion | 6.4 units on a scale | Standard Deviation 2.7 |
| 1DAM | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Ease of removal | 8.2 units on a scale | Standard Deviation 1.9 |
| 1DAM | Average Subjective Ratings Score (Lens Handling and Overall Vision) | Overall vision | 7.4 units on a scale | Standard Deviation 2.2 |
Secondary
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. Overall Vision was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Time frame: After 1 week of wear
Population: This analysis population includes all enrolled participants minus missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Sense of discomfort | 3.5 units on a scale | Standard Deviation 2.6 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | A lens comes off my eye | 2.4 units on a scale | Standard Deviation 2.2 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | A lens becomes out of place | 3.3 units on a scale | Standard Deviation 2.5 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Improves my vision/widens my vision | 6.3 units on a scale | Standard Deviation 2.4 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | My vision does not become blurry | 6.3 units on a scale | Standard Deviation 2.5 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Do not lose a sense of perspective/distance | 6.8 units on a scale | Standard Deviation 3.3 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Does not give me improper vision | 7.4 units on a scale | Standard Deviation 2.2 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Enables me to see clearly at important occasion | 6.9 units on a scale | Standard Deviation 2.4 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Improves my vision when playing sports | 6.6 units on a scale | Standard Deviation 2.5 |
| DACP | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Overall vision | 7.2 units on a scale | Standard Deviation 2.1 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Enables me to see clearly at important occasion | 6.5 units on a scale | Standard Deviation 2.2 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Sense of discomfort | 3.8 units on a scale | Standard Deviation 2.6 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Do not lose a sense of perspective/distance | 6.4 units on a scale | Standard Deviation 2.2 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | A lens comes off my eye | 2.5 units on a scale | Standard Deviation 2.2 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Overall vision | 7.1 units on a scale | Standard Deviation 1.9 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | A lens becomes out of place | 4.0 units on a scale | Standard Deviation 2.9 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Does not give me improper vision | 7.1 units on a scale | Standard Deviation 2.3 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Improves my vision/widens my vision | 5.8 units on a scale | Standard Deviation 2.4 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | Improves my vision when playing sports | 6.3 units on a scale | Standard Deviation 2 |
| 1DAM | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | My vision does not become blurry | 6.0 units on a scale | Standard Deviation 2.5 |
Secondary
Mean Investigator-Rated Lens Fit
Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.
Time frame: After 1 week of wear
Population: This analysis population includes all enrolled participants minus missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP | Mean Investigator-Rated Lens Fit | 0.24 units on a scale | Standard Deviation 0.42 |
| 1DAM | Mean Investigator-Rated Lens Fit | 0.28 units on a scale | Standard Deviation 0.5 |