Trial Outcomes & Findings for Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan (NCT NCT02103309)
NCT ID: NCT02103309
Last Updated: 2014-10-29
Results Overview
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.
COMPLETED
NA
42 participants
After 1 week of wear
2014-10-29
Participant Flow
Participants were recruited from 5 study centers located in Japan.
This reporting group includes all enrolled participants.
Participant milestones
| Measure |
DACP, Then 1DAM
Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
1DAM, Then DACP
Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan
Baseline characteristics by cohort
| Measure |
Overall
n=42 Participants
DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
|
|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After 1 week of wearPopulation: This analysis population includes all enrolled participants minus missing data.
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.
Outcome measures
| Measure |
DACP
n=41 Participants
Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
1DAM
n=39 Participants
Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
|---|---|---|
|
Mean Investigator-Rated Lens Centration
|
0.34 units on a scale
Standard Deviation 0.47
|
0.73 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: After 1 week of wearPopulation: This analysis population includes all enrolled participants minus missing data.
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.
Outcome measures
| Measure |
DACP
n=41 Participants
Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
1DAM
n=39 Participants
Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
|---|---|---|
|
Mean Investigator-Rated Lens Fit
|
0.24 units on a scale
Standard Deviation 0.42
|
0.28 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: After 1 week of wearPopulation: This analysis population includes all enrolled participants minus missing data.
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.
Outcome measures
| Measure |
DACP
n=42 Participants
Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
1DAM
n=42 Participants
Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
|---|---|---|
|
Average Subjective Ratings Score (Lens Handling and Overall Vision)
Ease of insertion
|
7.8 units on a scale
Standard Deviation 2.0
|
6.4 units on a scale
Standard Deviation 2.7
|
|
Average Subjective Ratings Score (Lens Handling and Overall Vision)
Ease of removal
|
7.2 units on a scale
Standard Deviation 2.5
|
8.2 units on a scale
Standard Deviation 1.9
|
|
Average Subjective Ratings Score (Lens Handling and Overall Vision)
Overall vision
|
8.1 units on a scale
Standard Deviation 1.9
|
7.4 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: After 1 week of wearPopulation: This analysis population includes all enrolled participants minus missing data.
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.
Outcome measures
| Measure |
DACP
n=42 Participants
Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
1DAM
n=42 Participants
Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
|
|---|---|---|
|
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
|
6.0 units on a scale
Standard Deviation 2.5
|
|
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
|
3.8 units on a scale
Standard Deviation 2.6
|
|
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
|
2.5 units on a scale
Standard Deviation 2.2
|
|
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
|
4.0 units on a scale
Standard Deviation 2.9
|
|
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
|
5.8 units on a scale
Standard Deviation 2.4
|
|
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
|
6.4 units on a scale
Standard Deviation 2.2
|
|
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
|
7.1 units on a scale
Standard Deviation 2.3
|
|
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
|
6.5 units on a scale
Standard Deviation 2.2
|
|
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
|
6.3 units on a scale
Standard Deviation 2.0
|
|
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
|
7.1 units on a scale
Standard Deviation 1.9
|
Adverse Events
DACP
1DAM
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER